sssohrab/ct-dosing-errors-benchmark · Datasets at Hugging Face

[ 3 ]

100

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

The objective of the trial was to establish the dose-response relation of sugammadex (Org 25969) given as a reversal agent of rocuronium or vecuronium at 1-2 PTC during sevoflurane anesthesia for Japanese participants.

null

Anesthesia, General

null

10

arm 1: After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered intravenously (IV), followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of the second twitch (T2) response to Train-of-four (TOF) stimulation, a single dose of 0.5 mg/kg sugammadex was administered IV. arm 2: After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV, followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of the T2 response to TOF stimulation, a single dose of 1.0 mg/kg sugammadex was administered IV. arm 3: After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV, followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of the T2 response to TOF stimulation, a single dose of 2.0 mg/kg sugammadex was administered IV. arm 4: After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV, followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of the T2 response to TOF stimulation, a single dose of 4.0 mg/kg sugammadex was administered IV. arm 5: After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV, followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of the T2 response to TOF stimulation, a single dose of 0.8 mg/kg sugammadex was administered IV. arm 6: After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.4 mg/kg vecuronium IV if necessary. At reappearance of the T2 response to TOF stimulation, a single dose of 0.5 mg/kg sugammadex was administered IV. arm 7: After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.4 mg/kg vecuronium IV if necessary. At reappearance of the T2 response to TOF stimulation, a single dose of 1.0 mg/kg sugammadex was administered IV. arm 8: After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.4 mg/kg vecuronium IV if necessary. At reappearance of the T2 response to TOF stimulation, a single dose of 2.0 mg/kg sugammadex was administered IV. arm 9: After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.4 mg/kg vecuronium IV if necessary. At reappearance of the T2 response to TOF stimulation, a single dose of 4.0 mg/kg sugammadex was administered IV. arm 10: After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.4 mg/kg vecuronium IV if necessary. At reappearance of the T2 response to TOF stimulation, a single dose of 8.0 mg/kg sugammadex was administered IV.

[ 0, 0, 0, 0, 0, 0, 0, 0, 0, 0 ]

1

[ 0 ]

intervention 1: After induction of anesthesia an intubation dose of a neuromuscular blocking agent (NMBA) was administered IV: either 0.9 mg/kg rocuronium (arms 1-5) or 0.1 mg/kg vecuronium (arms 6-10). Maintenance doses of 0.1-0.2 mg/kg rocuronium IV or 0.02-0.04 mg/kg vecuronium IV could be administered if necessary. At reappearance of T2 the randomized single dose of sugammadex (0.5 to 8.0 mg/kg) IV was administered.

intervention 1: Sugammadex

0

null

0

NCT00591786

[ 4 ]

162

NON_RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

The purpose of the study is to compare the effectiveness, safety and pharmacokinetics of sugammadex in participants 65 and over with participants under 65. There is no hypothesis defined for the study.

null

Anesthesia, General

null

3

arm 1: Participants to receive an intravenous (IV) single bolus dose of 0.6 mg.kg-1 rocuronium. If further neuromuscular block was required after endotracheal intubation, maintenance dose(s) of 0.15 mg.kg-1 rocuronium were to be administered. After the intubation dose or the last maintenance dose of rocuronium, participants were to be reversed at reappearance of second twitch (T2) with an intravenous single bolus dose of 2.0 mg.kg-1 of sugammadex. arm 2: Participants to receive an IV single bolus dose of 0.6 mg.kg-1 rocuronium. If further neuromuscular block was required after endotracheal intubation, maintenance dose(s) of 0.15 mg.kg-1 rocuronium were to be administered. After the intubation dose or the last maintenance dose of rocuronium, participants were to be reversed at reappearance of T2 with an intravenous single bolus dose of 2.0 mg.kg-1 of sugammadex. arm 3: Participants to receive an IV single bolus dose of 0.6 mg.kg-1 rocuronium. If further neuromuscular block was required after endotracheal intubation, maintenance dose(s) of 0.15 mg.kg-1 rocuronium were to be administered. After the intubation dose or the last maintenance dose of rocuronium, participants were to be reversed at reappearance of T2 with an intravenous single bolus dose of 2.0 mg.kg-1 of sugammadex.

[ 0, 0, 0 ]

2

[ 0, 0 ]

intervention 1: None intervention 2: intravenous (IV) single bolus dose of 0.6 mg.kg-1

intervention 1: Sugammadex intervention 2: Rocurium

0

null

1

NCT00474617

[ 4 ]

122

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

null

This study evaluates the safety of medicine on COPD (Chronic Obstructive Pulmonary Disease). This study will last up to 56 weeks, and subjects will visit the clinic 16 times. Subjects will be given breathing tests, and will record their breathing symptoms daily on diary cards.

null

Pulmonary Disease, Chronic Obstructive

Chronic Bronchitis COPD Emphysema

null

0

null

1

[ 0 ]

intervention 1: None

intervention 1: fluticasone propionate/salmeterol combination DISKUS

5

Kodaira | N/A | Japan | 139.48508 | 35.72603 Kyoto | N/A | Japan | 135.75385 | 35.02107 Osaka | N/A | Japan | 135.50107 | 34.69379 Tokyo | N/A | Japan | 139.69171 | 35.6895 N/A | N/A | N/A | N/A | N/A

0

NCT00269087

[ 4 ]

48

NON_RANDOMIZED

SINGLE_GROUP

1PREVENTION

0NONE

false

0ALL

false

This study is requested by PMDA to confirm the efficacy and the safety for HFS.

null

Thromboembolism

Xa factor VTE MOSLL pentasaccharide

null

0

null

1

[ 0 ]

intervention 1: None

intervention 1: Fondaparinux

1

N/A | N/A | N/A | N/A | N/A

0

NCT00320424

[ 5 ]

506

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

This study will compare two treatment strategies (doubling the dose of inhaled steroids or adding a long acting beta2 agonist to the inhaled steroid at the same dose) in children not controlled by inhaled steroid alone at medium dose. The fixed combination SERETIDE 100/50 one inhalation twice daily will be compared to FLIXOTIDE 100 two inhalations twice daily.

A multicentre, randomised, double-blind, double dummy, parallel group study to compare the salmeterol/fluticasone propionate combination (SERETIDE™) at a dose of 50/100mcg twice daily and fluticasone propionate (FLIXOTIDE™) at a dose of 200mcg twice daily, both delivered via a dry powder inhaler (DISKUS™) for 12 weeks in asthma in children aged 4-11 years not controlled by inhaled corticosteroids alone at medium dose

Asthma

FLIXOTIDE asthmatics children 4-11 years SERETIDE asthma-control

null

2

arm 1: Fluticasone propionate (FLIXOTIDE™) at a dose of 200μg twice daily arm 2: Salmeterol/fluticasone propionate combination (SERETIDE™) at a dose of 50/100μg twice daily

[ 1, 0 ]

2

[ 0, 0 ]

intervention 1: 200μg twice daily intervention 2: 50/100μg twice daily

intervention 1: Fluticasone propionate intervention 2: Fluticasone propionate/salmeterol

65

Bruges | N/A | Belgium | 3.22424 | 51.20892 Brussels | N/A | Belgium | 4.34878 | 50.85045 Edegem | N/A | Belgium | 4.44504 | 51.15662 Ghent | N/A | Belgium | 3.71667 | 51.05 Leuven | N/A | Belgium | 4.70093 | 50.87959 Aalborg | N/A | Denmark | 9.9187 | 57.048 Odense | N/A | Denmark | 10.38831 | 55.39594 Essey-lès-Nancy | N/A | France | 6.22691 | 48.705 Grasse | N/A | France | 6.92537 | 43.65783 Laon | N/A | France | 3.62714 | 49.5631 Nîmes | N/A | France | 4.35788 | 43.83665 Oyonnax | N/A | France | 5.65727 | 46.25917 Paris | N/A | France | 2.3488 | 48.85341 Paris | N/A | France | 2.3488 | 48.85341 Rouen | N/A | France | 1.09932 | 49.44313 Rouen | N/A | France | 1.09932 | 49.44313 Saint-Michel | N/A | France | 4.13278 | 49.91952 Tours | N/A | France | 0.70398 | 47.39484 Vaux En Velin | N/A | France | N/A | N/A Villejuif | N/A | France | 2.35992 | 48.7939 Foggia | Apulia | Italy | 15.55188 | 41.45845 Napoli | Campania | Italy | 14.5195 | 40.87618 Palermo | Sicily | Italy | 13.3636 | 38.1166 Perugia | Umbria | Italy | 12.38878 | 43.1122 Daugavpils | N/A | Latvia | 26.53333 | 55.88333 Riga | N/A | Latvia | 24.10589 | 56.946 Riga | N/A | Latvia | 24.10589 | 56.946 Kaunas | N/A | Lithuania | 23.90961 | 54.90272 Tauragė | N/A | Lithuania | 22.28972 | 55.25222 Vilnius | N/A | Lithuania | 25.2798 | 54.68916 Almere Stad | N/A | Netherlands | 5.21413 | 52.37025 Beek en Donk | N/A | Netherlands | 5.62603 | 51.54158 Deurne | N/A | Netherlands | 5.79722 | 51.46 Emmen | N/A | Netherlands | 6.90694 | 52.77917 Ermelo | N/A | Netherlands | 5.62222 | 52.29833 Nieuwegein | N/A | Netherlands | 5.08056 | 52.02917 Spijkenisse | N/A | Netherlands | 4.32917 | 51.845 The Hague | N/A | Netherlands | 4.29861 | 52.07667 Tiel | N/A | Netherlands | 5.42917 | 51.88667 Woerden | N/A | Netherlands | 4.88333 | 52.085 Drammen | N/A | Norway | 10.20449 | 59.74389 Kongsvinger | N/A | Norway | 11.99772 | 60.19049 Oslo | N/A | Norway | 10.74609 | 59.91273 Bialystok | N/A | Poland | 23.16433 | 53.13333 Krakow | N/A | Poland | 19.93658 | 50.06143 Lodz | N/A | Poland | 19.47395 | 51.77058 Lublin | N/A | Poland | 22.56667 | 51.25 Krasnoyarsk | N/A | Russia | 92.90765 | 56.02668 Moscow | N/A | Russia | 37.61556 | 55.75222 Moscow | N/A | Russia | 37.61556 | 55.75222 Moscow | N/A | Russia | 37.61556 | 55.75222 Novokuznetsk | N/A | Russia | 87.13599 | 53.75752 Novosibirsk | N/A | Russia | 82.94339 | 55.03442 St'Petersburg | N/A | Russia | N/A | N/A Syktyvkar | N/A | Russia | 50.80819 | 61.68523 Tomsk | N/A | Russia | 84.98204 | 56.50032 Almería | N/A | Spain | -2.45974 | 36.83814 Barcelona | N/A | Spain | 2.15899 | 41.38879 Madrid | N/A | Spain | -3.70256 | 40.4165 Madrid | N/A | Spain | -3.70256 | 40.4165 San Sebastián | N/A | Spain | -5.9 | 43.56667 Seville | N/A | Spain | -5.97317 | 37.38283 Sollentuna | N/A | Sweden | 17.95093 | 59.42804 Stockholm | N/A | Sweden | 18.06871 | 59.32938 Stockholm | N/A | Sweden | 18.06871 | 59.32938

0

NCT00353873

[ 4 ]

369

RANDOMIZED

PARALLEL

0TREATMENT

null

false

0ALL

false

This study evaluates the effect of medicines for type 2 diabetes and lipids control. This study will require about 6 office visits for lab tests and examinations. All study related medicines and medical examinations will be provided at no cost to the subjects.

null

Diabetes Mellitus, Type 2

Type 2 diabetes Type II

null

0

null

1

[ 0 ]

intervention 1: None

intervention 1: GSK523338

85

0

NCT00256867

[ 3 ]

38

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

false

The primary study objective was to evaluate the dose-dependent efficacy of eslicarbazepine acetate administered at doses of 600, 1200, and 1800 mg over a 3-week period, compared with placebo, as therapy in patients with acute mania. The secondary objectives of this study were to a) evaluate the safety and tolerability of eslicarbazepine acetate (BIA 2-093) administered at doses of 600, 1200, and 1800 mg compared with placebo, b) assess the duration to onset of action in the different dose groups, and c) monitor the appearance of depressive symptoms.

This was a phase II, double-blind, fixed multiple dose, randomised, placebo-controlled, multicentre clinical trial in patients with a diagnosis of bipolar I disorder who experienced an acute manic (including mixed) episode. Patients who met the selection criteria at randomisation visit (V) (V2, Day 1) were randomised to 1 of 4 treatment groups: 600, 1200, or 1800 mg eslicarbazepine acetate, or placebo. Patients started the assigned treatment on Day 1 and were followed for up to 3 weeks. On Day 10, patients who showed no improvement were switched to open-label escape therapy with an established antimanic therapy. Patients could have been hospitalized at screening or at any time during the study at the investigator's discretion. Following randomisation (V2, Day 1), patients were assessed on Days 3, 7, 10, 14, 21, 28, and 56, after which they could either enter a recurrence prevention study, or the study drug could be tapered off and they could undergo follow-up assessments.

BIPOLAR I DISORDER

BIPOLAR I DISORDER, Eslicarbazepine acetate

null

4

arm 1: Eslicarbazepine acetate 1800 mg arm 2: Eslicarbazepine acetate 1200 mg arm 3: Eslicarbazepine acetate 600 mg arm 4: Placebo pills

[ 0, 0, 0, 2 ]

4

[ 0, 0, 0, 0 ]

intervention 1: Eslicarbazepine acetate to be taken orally, was available as 600 mg tablets. intervention 2: Eslicarbazepine acetate to be taken orally, was available as 600 mg tablets. intervention 3: Eslicarbazepine acetate to be taken orally, was available as 600 mg tablets. intervention 4: Placebo sugar pills

intervention 1: Eslicarbazepine acetate 1800 mg intervention 2: Eslicarbazepine acetate 1200 mg intervention 3: Eslicarbazepine acetate 600 mg intervention 4: Placebo

0

null

1

NCT01824602

[ 3 ]

104

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

1FEMALE

null

The purpose of this study is to determine if E7389 is a safe and effective treatment for advanced/metastatic breast cancer.

The primary objective is to determine the response rate (RR) to E7389 monotherapy administered as an IV bolus of 1.4 mg/m\^2 on Days 1, 8, and 15 of a 28-Day cycle and on Days 1 and 8 of a 21-day cycle in patients with advanced/metastatic breast cancer treated with chemotherapy including an anthracycline and a taxane, with previously documented progression during or within six months following the last dose of prior chemotherapy. The secondary objectives are to evaluate: * The safety and tolerability of E7389 monotherapy in this patient population; * The antitumor activity of E7389 as determined by duration of response, time to progression, and overall survival; * Quality of life measured by the Functional Assessment of Cancer Therapy-Breast (FACT-B) questionnaire/tumor-related symptom improvement or worsening measured by pain intensity on a visual analog scale (VAS), analgesics consumption, weight changes and performance status (PS); * Tumor pharmacogenetics and their possible relationship to response (assessment of beta-tubulin isotype mRNA on biopsy sample) in patients who have signed a separate consent form

Breast Neoplasms

breast neoplasm breast cancer breast tumor

null

1

arm 1: None

[ 0 ]

1

[ 0 ]

intervention 1: The first cohort of subjects were to receive E7389 1.4 mg/m\^2 as an intravenous (IV) bolus on Days 1, 8, and 15 of a 28-day cycle. A second cohort of subjects was added and were to receive E7389 1.4 mg/m\^2 as an IV bolus on Days 1 and 8 of a 21-day cycle.

intervention 1: E7389

16

0

NCT00097721

[ 3 ]

460

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

2MALE

true

The rationale of the study was to evaluate different degarelix dosing regimens for a three-month interval that was to produce and maintain castration in prostate cancer patients through immediate and prolonged testosterone suppression, and to provide confirmatory evidence of the safety of degarelix.

null

Prostate Cancer

Prostate Cancer Androgen ablation therapy

null

3

arm 1: 240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (40 mg/mL) at months 1, 3, 6 and 9. arm 2: 240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 3, 6 and 9. arm 3: 240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 4, 7 and 10.

[ 1, 1, 1 ]

3

[ 0, 0, 0 ]

intervention 1: Drug: Degarelix subcutaneous 240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (40 mg/mL) at months 1, 3, 6 and 9 intervention 2: Drug: Degarelix subcutaneous 240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 3, 6 and 9 intervention 3: Drug: Degarelix subcutaneous 240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 4, 7 and 10

intervention 1: Degarelix intervention 2: Degarelix intervention 3: Degarelix

56

0

NCT00116753

[ 0 ]

10

RANDOMIZED

CROSSOVER

7BASIC_SCIENCE

2DOUBLE

false

0ALL

false

To investigate a possible interaction between formoterol and budesonide on GR-translocation and to compare the effect of different doses of Symbicort (80/4.5 and 2x80/4.5 mcg) with the effect of budesonide (200 mcg and 800 mcg) on GR translocation, and to investigate the effect of the study drugs on exhaled NO (bronchial and alveolar fraction.

Combination therapy with inhaled corticosteroids (ICS) and long-acting β(2)-adrenergic agonists (LABA) is reported to have superior effects on controlling asthma symptoms to ICS alone; however, there is no molecular-based evidence to explain the clinical effects. Here, the effect of the ICS/LABA combination was compared with ICS on glucocorticoid receptor (GR) activation in sputum macrophage. In a randomised, double-blind cross-over placebo-controlled 6-visit study, 10 patients with mild asthma were given placebo, formoterol (Oxis(®) 12 μg), budesonide (Pulmicort(®) 200 μg :BUD200, or 800 μg :BUD800), or budesonide/formoterol combination (Symbicort(®)) as a single 100/6 μg (SYM100) or double 200/12 μg (SYM200) dose. Sputum macrophages were separated by plate adhesion from induced sputum. GR binding to the glucocorticoid-response elements on oligonucleotides (GR-GRE binding) was evaluated by ELISA. mRNA expression of MAP-kinase phosphatase (MKP)-1 and IL-8 were measured by quantitative RT-PCR.

Asthma

Asthma Glucocorticoid Long-acting beta2-adrenoceptor Inhaled corticosteroids

null

6

arm 1: placebo arm 2: Oxis(®) 12 μg arm 3: Pulmicort(®) 200 μg arm 4: Pulmicort(®) 800 μg arm 5: single 100/6 μg SYM100 arm 6: double 200/12 μg SYM200

[ 2, 0, 0, 0, 0, 0 ]

4

[ 0, 0, 0, 0 ]

intervention 1: Dry powder inhaler intervention 2: 12ug intervention 3: Inhaler intervention 4: Combination Inhaler, Symbicort

intervention 1: Placebos intervention 2: Formoterol Inhalant Powder intervention 3: Budesonide Powder intervention 4: Budesonide and Formoterol Product

1

London | N/A | United Kingdom | -0.12574 | 51.50853

0

NCT00159263

[ 3 ]

133

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

null

0ALL

null

To evaluate efficacy and safety of E2014 (2500U, 5000U, 10000U, placebo) in a multicenter, randomized, double-blind, parallel group comparative study by intramuscularly administering to patients with spasmodic torticollis. Primary endpoint for efficacy evaluation is changes in TWSTRS total scores from baseline measured at Week 4 and the clinical recommended dose will be examined with Williams multiple comparison. For safety evaluation, an inter group comparison (active drug and placebo) will be performed mainly focusing on incidence of adverse events, adverse drug reactions, and abnormal changes in laboratory parameters.

null

Cervical Dystonia Spasmodic Torticollis

null

0

null

1

[ 0 ]

intervention 1: None

intervention 1: BOTULINUM TOXIN TYPE B

21

0

NCT00165776

[ 0 ]

101

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

null

Chronic suppurative otitis media is one of the most common chronic infections in children worldwide. Symptoms include otorrhea, otalgia and hearing loss. In many countries, it is treated primarily with antibiotics; in other countries such as the Netherlands a surgical approach, such as a tonsillectomy, adenoidectomy, placement or removal of tympanostomy tubes or a tympanomastoidectomy is preferred. There is however, no agreement on the management of this disease. The purpose of this study is to determine the effectiveness of treatment with sulfamethoxazole-trimethoprim for 6-12 weeks in children suffering from chronic otitis media and otorrhea.

Chronic suppurative otitis media is one of the most common chronic infections in children worldwide. Symptoms include otorrhea, otalgia and hearing loss. In many countries it is treated primarily with antibiotics; in other countries such as the Netherlands a surgical approach, such as a tonsillectomy, adenoidectomy, placement or removal of tympanostomy tubes or a tympanomastoidectomy is preferred. There is however, no agreement on the management of this disease. Co-trimoxazole is an inexpensive antibiotic and tolerated well by children, also when long treatment regimens or prophylaxis is necessary. A previously performed retrospective study of 48 children who were referred to the pediatric department of otorhinolaryngology in the UMC Utrecht because of "therapeutic resistant" otorrhea showed promising results; after 3 months follow-up, 52% of the patients were otorrhea free, 25% had otorrhea incidentally and 23% showed no signs of improvement. Therefore, the treatment of chronic otitis media with sulfamethoxazole-trimethoprim for a minimum of six weeks is promising and might be a good alternative to surgical treatment. The purpose of this study is to determine the effectiveness of treatment with sulfamethoxazole-trimethoprim during 6-12 weeks in children with chronic otitis media and otorrhea for more than 12 weeks.

Chronic Otitis Media

null

2

arm 1: None arm 2: None

[ 2, 1 ]

2

[ 0, 0 ]

intervention 1: 18 mg/kg, two times a day intervention 2: None

intervention 1: Sulfamethoxazole-trimethoprim intervention 2: Placebo

1

Utrecht | Utrecht | Netherlands | 5.12222 | 52.09083

0

NCT00189098

[ 5 ]

20

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

The purpose of this research study is to analyze the effectiveness and tolerability of a medication, valproate ( Depakote and Depakote ER), in individuals age 50 years and older who have schizophrenia.

It is known that up to 30% of individuals with schizophrenia continue to have symptoms even when treated with current FDA-approved medications intended to treat their schizophrenia. Anticonvulsant medications such as valproate (Depakote and Depakote ER) are known to be effective for related conditions such as bipolar disorder (manic depressive illness), and are also used by some physicians in clinical settings in combination with antipsychotic medications to treat symptoms of schizophrenia. Currently Depakote and Depakote ER are approved by the FDA to treat bipolar disorder and to treat seizure disorder. This study will test to see if Depakote and Depakote ER may improve symptoms of schizophrenia as well when added to antipsychotic medications.

Schizophrenia

Schizophrenia Anticonvulsants Valproic Acid Valproate

null

1

arm 1: All participants received open-label, add-on valproate.

[ 0 ]

1

[ 0 ]

intervention 1: Enrolled individuals received adjunctive, open-label valproate semisodium, initially started as valproate semisodium delayed -release 250 mg at bedtime for two weeks, then changed to valproate semisodium extended- release 500 mg at bedtime. Medication was administered on an outpatient/ambulatory basis, and adjusted as tolerated to target serum levels of 50-100 µg/mL. In cases where sedation or other side effects occurred, dosage was reduced. Valproate semisodium was prescribed in a single dose at bedtime.

intervention 1: Valproate

1

Cleveland | Ohio | United States | -81.69541 | 41.4995

0

NCT00194025

[ 2 ]

4

NA

SINGLE_GROUP

0TREATMENT

2DOUBLE

false

0ALL

false

The goal of this study is to demonstrate the effectiveness of pentoxifylline compared to placebo in AAH while studying putative mechanisms that are plausible and testable. The main hypothesis is that pentoxifylline reduces the 90-day mortality of AAH.

The goal of this study is to demonstrate the effectiveness of pentoxifylline compared to placebo in AAH while studying putative mechanisms that are plausible and testable. The main hypothesis is that pentoxifylline reduces the 90-day mortality of AAH. This study never moved forward due to funding issues.

Hepatitis, Alcoholic

acute alcoholic hepatitis

null

1

arm 1: All subjects will be randomized to receive either pentoxifylline 400mg orally or placebo 3 times daily for 28 days (20-40 treated, 1-20 placebo) with monthly follow up for 90 days.

[ 0 ]

1

[ 0 ]

intervention 1: daily dosing

intervention 1: pentoxifylline

0

null

0

NCT00205049

[ 3 ]

176

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

null

A study to assess the safety and efficacy of 2 different doses of CDP870 versus placebo, administered during 12 weeks, to patients suffering from moderate to severe chronic plaque psoriasis, extended by a 12 to 24 week follow-up.

null

Chronic Plaque Psoriasis

chronic plaque psoriasis, anti TNFα CDP870, Cimzia

null

3

arm 1: Subcutaneous injections of Placebo every 2 weeks arm 2: Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter arm 3: Subcutaneous injections of 400 mg every 2 weeks

[ 2, 0, 0 ]

2

[ 0, 10 ]

intervention 1: * Pharmaceutical Form: solution for injection in pre-filled syringe * Route of Administration: subcutaneous use intervention 2: Matching Placebo to Certolizumab Pegol

intervention 1: Certolizumab Pegol intervention 2: Placebo

15

Besançon | N/A | France | 6.01815 | 47.24878 Créteil | N/A | France | 2.46569 | 48.79266 Nice | N/A | France | 7.26608 | 43.70313 Paris | N/A | France | 2.3488 | 48.85341 Pierre-Bénite | N/A | France | 4.82424 | 45.70359 Saint-Etienne | N/A | France | 4.39 | 45.43389 Berlin | N/A | Germany | 13.41053 | 52.52437 Bonn | N/A | Germany | 7.09549 | 50.73438 Essen | N/A | Germany | 7.01228 | 51.45657 Frankfurt | N/A | Germany | 10.53333 | 49.68333 Göttingen | N/A | Germany | 9.93228 | 51.53443 Hamburg | N/A | Germany | 9.99302 | 53.55073 Kiel | N/A | Germany | 10.13489 | 54.32133 Mainz | N/A | Germany | 8.2791 | 49.98419 Münster | N/A | Germany | 7.62571 | 51.96236

0

NCT00245765

[ 4 ]

830

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

null

The purpose of this study is to compare the efficacy of pitavastatin with that of atorvastatin.

Following a wash-out dietary lead-in period, patients will receive either Atorvastatin or Pitavastatin during 12 weeks, in order to establish the efficacy of pitavastatin in reducing cholesterol levels.

Primary Hypercholesterolemia Dyslipidemia

hypercholesterolemia dyslipidemia kowa KRE pitavastatin NK-104

null

0

null

2

[ 0, 0 ]

intervention 1: None intervention 2: None

intervention 1: Pitavastatin intervention 2: Atorvastatin

192

Copenhagen | N/A | Denmark | 12.56553 | 55.67594 Copenhagen | N/A | Denmark | 12.56553 | 55.67594 Copenhagen Nv | N/A | Denmark | N/A | N/A Frederiksberg | N/A | Denmark | 12.53463 | 55.67938 Hellerup | N/A | Denmark | 12.57093 | 55.73204 Vejle | N/A | Denmark | 9.5357 | 55.70927 Helsinki | N/A | Finland | 24.93545 | 60.16952 Helsinki | N/A | Finland | 24.93545 | 60.16952 Helsinki | N/A | Finland | 24.93545 | 60.16952 Tampere | N/A | Finland | 23.78712 | 61.49911 Turku | N/A | Finland | 22.26869 | 60.45148 Bad Soden/Taunus | N/A | Germany | N/A | N/A Beckum | N/A | Germany | 8.04075 | 51.75571 Berlin | N/A | Germany | 13.41053 | 52.52437 Berlin-Spandau | N/A | Germany | N/A | N/A Chemnitz | N/A | Germany | 12.92922 | 50.8357 Dresden | N/A | Germany | 13.73832 | 51.05089 Frankfurt am Main | N/A | Germany | 8.68417 | 50.11552 Goch | N/A | Germany | 6.15895 | 51.67873 Hamburg | N/A | Germany | 9.99302 | 53.55073 Heidelberg | N/A | Germany | 8.69079 | 49.40768 Lampertheim | N/A | Germany | 8.4725 | 49.59786 Leipzig | N/A | Germany | 12.37129 | 51.33962 Mainz | N/A | Germany | 8.2791 | 49.98419 Mannheim | N/A | Germany | 8.46694 | 49.4891 Melcherstaette | N/A | Germany | N/A | N/A Messkirch | N/A | Germany | 9.11479 | 47.99457 Offenbach/M | N/A | Germany | N/A | N/A Weinheim | N/A | Germany | 8.66697 | 49.54887 Wiesbaden | N/A | Germany | 8.24932 | 50.08258 Worpswede | N/A | Germany | 8.93333 | 53.21667 Andhra Pradesh | N/A | India | N/A | N/A Andhra Pradesh | N/A | India | N/A | N/A Andhra Pradesh | N/A | India | N/A | N/A Bangalore | N/A | India | 77.59369 | 12.97194 Chennai | N/A | India | 80.27847 | 13.08784 Gujarat | N/A | India | N/A | N/A Hyderabaad | N/A | India | N/A | N/A Hyderabaad | N/A | India | N/A | N/A Karnataka | N/A | India | N/A | N/A Karnataka | N/A | India | N/A | N/A Maharashtra | N/A | India | N/A | N/A Maharashtra | N/A | India | N/A | N/A Maharashtra | N/A | India | N/A | N/A Maharashtra | N/A | India | N/A | N/A Maharashtra | N/A | India | N/A | N/A Maharashtra | N/A | India | N/A | N/A Mumbai | N/A | India | 72.88261 | 19.07283 New Delhi | N/A | India | 77.2148 | 28.62137 New Delhi | N/A | India | 77.2148 | 28.62137 Tamil Nadu | N/A | India | N/A | N/A Tamil Nadu | N/A | India | N/A | N/A Beersheva | N/A | Israel | N/A | N/A Haifa | N/A | Israel | 34.99928 | 32.81303 Holon | N/A | Israel | 34.77918 | 32.01034 Jerusalem Ein Kerem | N/A | Israel | N/A | N/A Kfar Saba | N/A | Israel | 34.90694 | 32.175 Mount Scopus Jerusalem | N/A | Israel | N/A | N/A Safed | N/A | Israel | 35.496 | 32.96465 Tel Aviv | N/A | Israel | 34.78057 | 32.08088 Tel Litwinsky | N/A | Israel | 34.84588 | 32.05096 Bologna | N/A | Italy | 11.33875 | 44.49381 Chieti | N/A | Italy | 14.16494 | 42.34827 Ferrara | N/A | Italy | 11.62057 | 44.83804 Genova | N/A | Italy | 11.87211 | 45.21604 Modena | N/A | Italy | 10.92539 | 44.64783 Napoli | N/A | Italy | 14.5195 | 40.87618 Palermo | N/A | Italy | 13.3636 | 38.1166 Parma | N/A | Italy | 10.32618 | 44.79935 Treviglio | N/A | Italy | 9.59102 | 45.52081 Trieste | N/A | Italy | 13.77678 | 45.64953 Breda | N/A | Netherlands | 4.77596 | 51.58656 Breda | N/A | Netherlands | 4.77596 | 51.58656 Eindhoven | N/A | Netherlands | 5.47778 | 51.44083 Eindhoven | N/A | Netherlands | 5.47778 | 51.44083 Groningen | N/A | Netherlands | 6.56667 | 53.21917 Groningen | N/A | Netherlands | 6.56667 | 53.21917 Hoorn | N/A | Netherlands | 5.05972 | 52.6425 Leiden | N/A | Netherlands | 4.49306 | 52.15833 Leiden | N/A | Netherlands | 4.49306 | 52.15833 Nijmegen | N/A | Netherlands | 5.85278 | 51.8425 Nijmegen | N/A | Netherlands | 5.85278 | 51.8425 Rotterdam | N/A | Netherlands | 4.47917 | 51.9225 Rotterdam | N/A | Netherlands | 4.47917 | 51.9225 Sliedrecht | N/A | Netherlands | 4.77639 | 51.82083 Velp | N/A | Netherlands | 5.97361 | 51.995 Velp | N/A | Netherlands | 5.97361 | 51.995 Wp Tiel | N/A | Netherlands | N/A | N/A Zoetermeer | N/A | Netherlands | 4.49306 | 52.0575 Zoetermeer | N/A | Netherlands | 4.49306 | 52.0575 Fredrikstad | N/A | Norway | 10.9298 | 59.2181 Kongsberg | N/A | Norway | 9.65017 | 59.66858 Oslo | N/A | Norway | 10.74609 | 59.91273 Oslo | N/A | Norway | 10.74609 | 59.91273 Skedsmokorset | N/A | Norway | 11.03278 | 60.00459 Bialystok | N/A | Poland | 23.16433 | 53.13333 Gruziadz | N/A | Poland | N/A | N/A Katowice | N/A | Poland | 19.02754 | 50.25841 Siedlce | N/A | Poland | 22.29006 | 52.16772 Tarnów | N/A | Poland | 20.98698 | 50.01381 Tychy | N/A | Poland | 18.96641 | 50.13717 Warsaw | N/A | Poland | 21.01178 | 52.22977 Warsaw | N/A | Poland | 21.01178 | 52.22977 Warsaw | N/A | Poland | 21.01178 | 52.22977 Łosice | N/A | Poland | 22.71801 | 52.21129 Kemerovo | N/A | Russia | 86.08333 | 55.33333 Moscow | N/A | Russia | 37.61556 | 55.75222 Moscow | N/A | Russia | 37.61556 | 55.75222 Moscow | N/A | Russia | 37.61556 | 55.75222 Moscow | N/A | Russia | 37.61556 | 55.75222 Moscow | N/A | Russia | 37.61556 | 55.75222 Moscow | N/A | Russia | 37.61556 | 55.75222 Moscow | N/A | Russia | 37.61556 | 55.75222 Moscow | N/A | Russia | 37.61556 | 55.75222 Moscow | N/A | Russia | 37.61556 | 55.75222 Moscow | N/A | Russia | 37.61556 | 55.75222 Moscow | N/A | Russia | 37.61556 | 55.75222 Moscow | N/A | Russia | 37.61556 | 55.75222 Moscow | N/A | Russia | 37.61556 | 55.75222 Moscow | N/A | Russia | 37.61556 | 55.75222 Moscow | N/A | Russia | 37.61556 | 55.75222 Moscow | N/A | Russia | 37.61556 | 55.75222 Novosibirsk | N/A | Russia | 82.94339 | 55.03442 Saint Petersburg | N/A | Russia | 30.31413 | 59.93863 Saint Petersburg | N/A | Russia | 30.31413 | 59.93863 Saint Petersburg | N/A | Russia | 30.31413 | 59.93863 Saint Petersburg | N/A | Russia | 30.31413 | 59.93863 Saint Petersburg | N/A | Russia | 30.31413 | 59.93863 Saint Petersburg | N/A | Russia | 30.31413 | 59.93863 Saint Petersburg | N/A | Russia | 30.31413 | 59.93863 Saint Petersburg | N/A | Russia | 30.31413 | 59.93863 Saint Petersburg | N/A | Russia | 30.31413 | 59.93863 Saint Petersburg | N/A | Russia | 30.31413 | 59.93863 San Juan | Alicante | Spain | -1.16667 | 39.53333 Villaroel | Barcelona | Spain | N/A | N/A Alicante | N/A | Spain | -0.48149 | 38.34517 Barcelona | N/A | Spain | 2.15899 | 41.38879 Barcelona | N/A | Spain | 2.15899 | 41.38879 Barcelona | N/A | Spain | 2.15899 | 41.38879 Barcelona | N/A | Spain | 2.15899 | 41.38879 Córdoba | N/A | Spain | -4.77275 | 37.89155 Madrid | N/A | Spain | -3.70256 | 40.4165 Madrid | N/A | Spain | -3.70256 | 40.4165 Madrid | N/A | Spain | -3.70256 | 40.4165 Madrid | N/A | Spain | -3.70256 | 40.4165 Oviedo | N/A | Spain | -5.84476 | 43.36029 Santander | N/A | Spain | -3.80444 | 43.46472 Santiago de Compostela | N/A | Spain | -8.54569 | 42.88052 Seville | N/A | Spain | -5.97317 | 37.38283 Valencia | N/A | Spain | -0.37966 | 39.47391 Zaragoza | N/A | Spain | -0.87734 | 41.65606 Zaragoza | N/A | Spain | -0.87734 | 41.65606 Angelhom | N/A | Sweden | N/A | N/A Gothenburg | N/A | Sweden | 11.96679 | 57.70716 Helsingborg | N/A | Sweden | 12.69437 | 56.04673 Karineholm | N/A | Sweden | N/A | N/A Ludvika | N/A | Sweden | 15.18776 | 60.14959 Sandviken | N/A | Sweden | 16.76667 | 60.61667 Sandviken | N/A | Sweden | 16.76667 | 60.61667 Södertälje | N/A | Sweden | 17.62525 | 59.19554 Stockholm | N/A | Sweden | 18.06871 | 59.32938 Varberg | N/A | Sweden | 12.25078 | 57.10557 Bath | N/A | United Kingdom | -2.36172 | 51.3751 Bath | N/A | United Kingdom | -2.36172 | 51.3751 Bath | N/A | United Kingdom | -2.36172 | 51.3751 Bath | N/A | United Kingdom | -2.36172 | 51.3751 Birmingham | N/A | United Kingdom | -1.89983 | 52.48142 Bolton | N/A | United Kingdom | -2.43333 | 53.58333 Chesterfield | N/A | United Kingdom | -1.41667 | 53.25 Chorley | N/A | United Kingdom | -2.61667 | 53.65 Cornwall | N/A | United Kingdom | N/A | N/A Dronfield | N/A | United Kingdom | -1.47507 | 53.30221 Irvine | N/A | United Kingdom | -4.65508 | 55.6194 Liverpool | N/A | United Kingdom | -2.97794 | 53.41058 Maidenhead | N/A | United Kingdom | -0.71986 | 51.52279 Manchester | N/A | United Kingdom | -2.23743 | 53.48095 Nottingham | N/A | United Kingdom | -1.15047 | 52.9536 Plymouth | N/A | United Kingdom | -4.14305 | 50.37153 Reading | N/A | United Kingdom | -0.97113 | 51.45625 Sheffield | N/A | United Kingdom | -1.4659 | 53.38297 Sheffield | N/A | United Kingdom | -1.4659 | 53.38297 Southampton | N/A | United Kingdom | -1.40428 | 50.90395 Surrey | N/A | United Kingdom | N/A | N/A Wiltshire | N/A | United Kingdom | N/A | N/A Wiltshire | N/A | United Kingdom | N/A | N/A Wiltshire | N/A | United Kingdom | N/A | N/A Wiltshire | N/A | United Kingdom | N/A | N/A Wiltshire | N/A | United Kingdom | N/A | N/A Wiltshire | N/A | United Kingdom | N/A | N/A Wiltshire | N/A | United Kingdom | N/A | N/A Wiltshire | N/A | United Kingdom | N/A | N/A Yorkshire | N/A | United Kingdom | N/A | N/A

0

NCT00249249

[ 5 ]

152

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

This study hopes to determine the appropriate oral steroid dose for treating children hospitalized with asthma exacerbations. Practice guidelines from different countries recommend a wide range of doses, and the doses used in actual practice vary widely. There is no data on what is the most appropriate dose of prednisone (or equivalent) in this situation. We will be looking at the dose recommended by the National Asthma Education and Prevention Program guidelines, which are published by the National Heart, Lung, and Blood Institute, as compared with a lower dose which is commonly used in practice. We hypothesize that the lower dose will be no worse than the higher dose as determined primarily by duration of hospitalization.

Practice guidelines for the management of asthma in children universally recommend systemic corticosteroids for the treatment of moderate to severe asthma exacerbations. However, these guidelines vary widely with respect to dose, frequency, method of delivery, and duration of therapy. In actual practice, there is also considerable variation among clinicians in terms of corticosteroid dosing in children hospitalized with asthma exacerbations. At the Children's Hospital of Philadelphia (CHOP) the current standard is to use an initial dose of 4.0 mg/kg/day (1.0 mg/kg every 6 hours to a maximum of 30 mg/dose) although many other pediatric hospitals use a 2.0 mg/kg/day dose (1.0 mg/kg every 12 hours to a maximum of 30 mg/dose). Systematic reviews of the literature have called for a clinical trial to evaluate the effect of different doses of corticosteroids in treating pediatric asthma patients hospitalized with exacerbations. This study will use a randomized, double-blind, controlled trial design in order to compare the efficacy of two different steroid doses in resolving acute exacerbations of asthma in hospitalized children. Children being hospitalized for asthma exacerbations from the CHOP emergency department (ED) will be eligible for study enrollment. Those that meet enrollment criteria will be randomized to receive prednisolone either in the higher dose (1.0 mg/kg (max 30 mg) every 6 hours), or the lower dose (1.0 mg/kg (max 30 mg) every 12 hours and placebo doses at 6 hour intervals in between) for the first 48 hours of hospitalization. Once 48 hours has past, all patients still hospitalized will receive 1.0 mg/kg (max 30 mg) every 12 hours for the duration of hospitalization. Approximately 156 patients with 78 in each arm of the study will be enrolled. This study should be completed in six to eight months. A non-inferiority study design will be used. The primary outcome will be duration of hospitalization, as determined by duration of time elapsed from first dose of prednisolone administered in the emergency department (ED) until the discharge dose of albuterol is administered. Secondary outcomes will include time elapsed from the time the admission order is written until the discharge order is written, time spent in each severity level of the asthma care pathway, degree and rate of improvement in forced expiratory volume in one second (FEV1), improvement in peak expiratory flows (PEF), improvement in asthma symptom scores, and rate of relapse after discharge.

Asthma

Corticosteroids Treatment Pediatric

null

2

arm 1: High dose prednisolone arm 2: Lower dose prednisolone alternating with placebo

[ 1, 0 ]

2

[ 0, 0 ]

intervention 1: 4 mg/kg/day orally divided every 6 hours (maximum 30 mg per dose) intervention 2: 2 mg/kg/day orally divided q 12 (maximum 30mg/dose) alternating with placebo

intervention 1: Prednisolone high dose intervention 2: Prednisolone lower dose

1

Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238

0

NCT00257933

[ 4 ]

34

RANDOMIZED

CROSSOVER

0TREATMENT

2DOUBLE

false

0ALL

null

The primary efficacy objective of this study is to compare the coefficient of fat absorption (CFA) following oral administration of Aptalis Pharma's (formerly Eurand Pharmaceuticals) pancreatic enzyme product (PEP) capsules and placebo in participants with cystic fibrosis (CF) and exocrine pancreatic insufficiency (EPI).

This is a randomized, double-blind, placebo-controlled, 2-treatment, crossover, multicenter trial in participants with CF and EPI. The study consists of a screening period (1 to 14 days), a washout period (2 days), a dose titration/stabilization period (6 to 9 days), a blinded randomized treatment period (6 to 7 days), an open-label normalization period 1 (5 to 14 days), a blinded crossover treatment period (6 to 7 days), followed by an open-label normalization period 2 (7 days). The order of treatments (placebo followed by EUR-1008 \[APT-1008\] or EUR-1008 \[APT-1008\] followed by placebo) will be determined by randomization at the beginning of randomization treatment period only and will be carried through the crossover treatment period. The starting dose will be 1,000 lipase units per kilogram per meal (lipase units/kg/meal), which will be titrated to control symptoms of EPI, with the total dose not exceeding 10,000 lipase units/kg/day.

Cystic Fibrosis Exocrine Pancreatic Insufficiency

CF Cystic Fibrosis EPI Exocrine Pancreatic Insufficiency Pancreatic Enzyme PEP

null

2

arm 1: None arm 2: None

[ 0, 0 ]

4

[ 0, 0, 0, 0 ]

intervention 1: EUR-1008 (APT-1008) microtablets (5000 lipase units) or minitablets (10000, 15000 or 20000 lipase units) contained in a capsule will be given orally daily in first double-blind intervention period; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). The capsules could be opened and sprinkled on acidic food and half of the established dose was used with snacks. Treatment duration for first double-blind intervention period will be 2 days home treatment and 3 to 5 days hospital treatment. intervention 2: Placebo matched to EUR-1008 (APT-1008) microtablets or minitablets contained in a capsule will be given orally daily in second double-blind intervention period; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). Treatment duration for second double-blind intervention period will be 2 days home treatment and 3 to 5 days hospital treatment. intervention 3: Placebo matched to EUR-1008 (APT-1008) microtablets or minitablets contained in a capsule will be given orally daily in first double-blind intervention period; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). Treatment duration for first double-blind intervention period will be 2 days home treatment and 3 to 5 days hospital treatment. intervention 4: EUR-1008 (APT-1008) microtablets (5000 lipase units) or minitablets (10000, 15000 or 20000 lipase units) contained in a capsule will be given orally daily in second double-blind intervention period; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). Treatment duration for second double-blind intervention period will be 2 days home treatment and 3 to 5 days hospital treatment.

intervention 1: EUR-1008 (APT-1008) intervention 2: Placebo intervention 3: Placebo intervention 4: EUR-1008 (APT-1008)

1

Tyler | Texas | United States | -95.30106 | 32.35126

0

NCT00297167

[ 5 ]

401

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

This study will hope to show that by relieving the participant's nasal symptoms of seasonal allergies using mometasone furoate nasal spray, the participant will obtain a better quality of night-time sleep, which in turn, causes less daytime sleepiness so that he/she can function productively during the day.

null

Seasonal Allergic Rhinitis

null

2

arm 1: Mometasone Furoate Nasal Spray 200 mcg, once daily. arm 2: None

[ 0, 2 ]

2

[ 0, 10 ]

intervention 1: MFNS 50 mcg/spray: self-administered, two sprays per nostril (ie, 200 mcg QD), once daily (each morning), for 28 days. intervention 2: Matching placebo nasal spray: 2 sprays per nostril once daily for 28 days

intervention 1: Mometasone Furoate Nasal Spray (MFNS) intervention 2: Placebo

0

null

0

NCT00358527

[ 4 ]

392

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

null

This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group Phase 3 study of Vytorin 10/10 (ezetimibe 10 mg with simvastatin 10 mg), Vytorin 10/20 (ezetimibe 10 mg with simvastatin 20 mg), and Vytorin 10/40 (ezetimibe 10 mg with simvastatin 40 mg) compared to placebo administered daily for 8 consecutive weeks in subjects with primary hypercholesterolemia (LDL-C \>3.64 mmol/L \[140 mg/dL\]). The efficacy of daily Vytorin versus placebo in reducing the concentration of LDL-C will be evaluated, and the efficacy of daily Vytorin versus placebo with respect to change in the concentrations of total cholesterol, triglycerides, and HDL-C will be compared. The safety of Vytorin versus placebo will also be assessed.

null

Hypercholesterolemia

null

4

arm 1: Ezetimibe 10 mg with Simvastatin 10 mg arm 2: Ezetimibe 10 mg with Simvastatin 20 mg arm 3: Ezetimibe 10 mg with Simvastatin 40 mg arm 4: None

[ 0, 0, 0, 2 ]

4

[ 0, 0, 0, 0 ]

intervention 1: Ezetimibe 10 mg with Simvastatin 10 mg once daily for a total of eight weeks intervention 2: Ezetimibe 10 mg with Simvastatin 20 mg once daily for a total of eight weeks intervention 3: Ezetimibe 10 mg with Simvastatin 40 mg once daily for a total of eight weeks intervention 4: Placebo once daily for a total of eight weeks

intervention 1: ezetimibe with simvastatin intervention 2: Ezetimibe with Simvastatin intervention 3: Ezetimibe with Simvastatin intervention 4: Placebo

0

null

0

NCT00413972

[ 4 ]

1,162

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

This study, in children with chronic asthma, evaluates the number of days of worsening asthma during 8 weeks of treatment with montelukast after treatment is started for the first day of school.

null

Asthma

null

2

arm 1: montelukast arm 2: Placebo

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: montelukast 5 mg tablet Once a day (QD) for 8 weeks intervention 2: Placebo to montelukast QD for 8 weeks

intervention 1: montelukast intervention 2: Comparator: Placebo

0

null

0

NCT00461032

[ 3 ]

59

RANDOMIZED

PARALLEL

0TREATMENT

1SINGLE

false

0ALL

false

This study was a Multicenter, Randomized, Blinded Study Comparing the Effect of CRx-102 Plus DMARD Therapy to that of Placebo Plus DMARD Therapy on Serum C Reactive Protein (CRP) and Cytokines in Subjects with Rheumatoid Arthritis. This Phase II, 6-week blinded study was planned for 60 subjects with moderate to severe rheumatoid arthritis (RA).

The primary objective of this study was to: • Compare the response of CRx-102 plus DMARD therapy to placebo plus DMARD therapy in lowering CRP levels in rheumatoid arthritis subjects. The secondary objectives of this study were to: * Evaluate the changes in inflammatory cytokines in subjects treated with CRx-102 plus DMARD therapy to placebo plus DMARD therapy. * Evaluate the efficacy of CRx-102 plus DMARD therapy to placebo plus DMARD therapy using ACR-20 and DAS28 indices as well as fatigue scales.

Rheumatoid Arthritis

Rheumatoid Arthritis RA DMARD CRP

null

2

arm 1: None arm 2: None

[ 0, 2 ]

3

[ 0, 0, 0 ]

intervention 1: None intervention 2: None intervention 3: DMARD therapy can include methotrexate or other DMARD therapy

intervention 1: CRx-102 intervention 2: Placebo intervention 3: DMARD Therapy

0

null

0

NCT00747214

[ 2 ]

60

RANDOMIZED

CROSSOVER

9OTHER

0NONE

true

0ALL

false

The objective of this study was to compare the oral availability of a test product of Mycophenolate Mofetil 250 mg capsule to an equivalent oral dose of the commercially available reference product, CellCept® 250 mg capsule administered to healthy subjects under fed conditions.

Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA bioequivalence statistical methods

Healthy

Bioequivalence Healthy Subjects

null

2

arm 1: Mycophenolate Mofetil 250 mg Capsule dosed in first period followed by Cellcept® 250 mg Capsule dosed in second period. arm 2: CellCept® 250 mg Capsule dosed in first period followed by Mycophenolate Mofetil 250 mg Capsule dosed in second period.

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: 250 mg Capsule intervention 2: 250 mg Capsule

intervention 1: Mycophenolate Mofetil intervention 2: CellCept®

1

Austin | Texas | United States | -97.74306 | 30.26715

0

NCT00910663

[ 4 ]

454

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

1FEMALE

false

Estradiol treatment is effective at reducing vasomotor symptoms (eg hot flushes) in postmenopausal women. This study will evaluate the safety and efficacy of Evamist.

Multicenter, randomized, double-blind, placebo-controlled trial evaluating different doses of transdermal estradiol delivered by sray to symptomatic postmenopausal women. The endpoints are the reduction in frequency and severity of hot flushes.

Hot Flashes

Postmenopause Hot Flashes Estradiol Polyestradiol phosphate Estradiol valerate Estradiol 3-benzoate Estradiol 17 beta-cypionate Estrogens Hormones Hormones, Hormone Substitutes Hormone Antagonists

null

6

arm 1: Placebo transdermal spray, three 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator arm 2: Placebo transdermal spray, two 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator arm 3: Placebo transdermal spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator arm 4: Estradiol transdermal spray, three 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator arm 5: Estradiol transdermal spray, two 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator arm 6: Estradiol transdermal spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator

[ 2, 2, 2, 1, 1, 1 ]

6

[ 0, 0, 0, 0, 0, 0 ]

intervention 1: Estradiol transdermal spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator intervention 2: Estradiol transdermal spray, two 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator intervention 3: Estradiol transdermal spray, three 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator intervention 4: Placebo transdermal spray, two 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator intervention 5: Placebo transdermal spray, three 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator intervention 6: Placebo transdermal spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator

intervention 1: Estradiol transdermal one 90 μL spray intervention 2: Estradiol transdermal spray, two 90 μL sprays intervention 3: Estradiol transdermal three 90 μL sprays intervention 4: Placebo transdermal two 90 μL sprays intervention 5: Placebo transdermal three 90 μL sprays intervention 6: Placebo transdermal one 90 μL spray

43

0

NCT01389102

[ 3 ]

36

RANDOMIZED

CROSSOVER

0TREATMENT

2DOUBLE

false

0ALL

null

Primary objective: To investigate bronchodilator effect and safety of single doses of BI 1744 CL inhaled via Respimat inhaler, Secondary objective: to characterize pharmacokinetics of BI 1744 CL. Olodaterol dose 40 mcg was investigated only in the open-label extension part for additional PK assessments which are not defined as primary or secondary endpoints.

null

Pulmonary Disease, Chronic Obstructive

null

6

arm 1: solution for inhalation arm 2: solution for inhalation arm 3: solution for inhalation arm 4: solution for inhalation arm 5: solution for inhalation arm 6: solution for inhalation

[ 0, 0, 0, 0, 0, 2 ]

6

[ 0, 0, 0, 0, 0, 0 ]

intervention 1: solution for inhalation intervention 2: solution for inhalation intervention 3: solution for inhalation intervention 4: solution for inhalation intervention 5: solution for inhalation intervention 6: solution for inhalation

intervention 1: single dose of 5 mcg intervention 2: single dose of placebo intervention 3: single dose of 40 mcg intervention 4: single dose of 20 mcg intervention 5: single dose of 2 mcg intervention 6: single dose of 10 mcg

1

Heerlen | N/A | Netherlands | 5.98154 | 50.88365

0

NCT01809262

[ 3 ]

161

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

Multicentre, double-blind, randomised, parallel-group, placebo-controlled dose-titration study; depending on clinical efficacy, up-titration of dosage 3 and 6 days after start of treatment; maintenance of individual maximum dose for the rest of the total 3-week treatment period; subsequently, down-titration (according to the dose steps and the time intervals of up-titration) and administration of an established anti-manic therapy during the tapering-off period (in patients who discontinued treatment) or entry into a recurrence prevention study (Protocol PRA+SCO/BIA-2093-205; reported under separate cover) as an option for patients who responded to the study treatment

Objectives: The primary objective was to evaluate the dose-dependent efficacy of 2 dose-titration regimens of Eslicarbazepine Acetate (ESL) compared with placebo as therapy in patients with acute mania. The secondary objective was to evaluate the safety and tolerability of 2 dose-titration regimens of Eslicarbazepine Acetate in comparison to placebo.

Bipolar I Disorder

null

3

arm 1: Group 1: Eslicarbazepine Acetate, starting with 800 mg per day and up-titrated in 800 mg steps until 2400 mg (maximum dose) according to clinical response. arm 2: Group 2: Eslicarbazepine Acetate, starting with 600 mg per day and up-titrated in 600 mg steps until 1800 mg (maximum dose) according to clinical response. arm 3: Group 3: Placebo (change in daily number of tablets administered, according to clinical response).

[ 0, 0, 2 ]

3

[ 0, 0, 0 ]

intervention 1: Eslicarbazepine Acetate, starting with 800 mg per day and up-titrated in 800 mg steps until 2400 mg (maximum dose) according to clinical response. intervention 2: Eslicarbazepine Acetate, starting with 600 mg per day and up-titrated in 600 mg steps until 1800 mg (maximum dose) according to clinical response. intervention 3: Placebo

intervention 1: Eslicarbazepine Acetate intervention 2: Eslicarbazepine Acetate intervention 3: Placebo

0

null

0

NCT01822678

[ 3 ]

310

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

This is a multi-center, open-label study to evaluate whether participants follow the duration of use instructions for short-term use of alclometasone dipropionate in a population of participants with itchy skin conditions who would use OTC treatments for relief. The study population will be composed of two different cohorts: chronic condition sufferers (eczema or psoriasis) and participants who suffer from occasional itchy skin experiences (such as poison ivy, oak, sumac, insect bites, or skin irritations due to jewelry, cosmetics, detergents, or soaps) where an anti-itch medication would be used.

Approximately 313 participants who are currently suffering from an itchy skin condition caused by eczema or psoriasis or any occasional itchy skin experiences will be enrolled into the study to get 250 participants who complete the study (at least 100 to each of the cohorts). After evaluation of the study criteria, the site staff will dispense product and a diary card to the subject to use over the next 14 days. At the end of the 14 days, each participant will come to the research site to return the remaining product and undergo the study termination interview with the Concentrics nurse via telephone. The study will be conducted in approximately 15 research sites located throughout the United States (US).

Eczema Allergy Symptoms Psoriasis Itch

Alclometasone dipropionate Eczema Psoriasis Itch

null

1

arm 1: Alclometasone dipropionate cream 0.05% will be applied by the participants topically on the affected areas per label instructions for 14 days.

[ 0 ]

1

[ 0 ]

intervention 1: Alclometasone dipropionate cream 0.05% (15 g)

intervention 1: Alclometasone dipropionate cream

0

null

0

NCT02075632

[ 3 ]

60

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

null

The purpose of this study is to determine the pathological complete tumor response rate.

null

Rectal Cancer

null

1

arm 1: Eligible participants received capecitabine 1000 milligrams per square meter (mg/m\^2) on Days 1-14, and 825 mg/m\^2 on Days 22-35 and 43-56 twice a day (bid) orally, along with oxaliplatin as a 2-hour intravenous (iv) infusion of 130 mg/m\^2/once a day (d) on Day 1 and 50 mg/m\^2/d on Days 22, 29, 43 and 50 prior to radiotherapy. Participants received radiation therapy having a fraction dose of 1.8 gray (Gy)/day, 5 days a week, for five consecutive weeks starting on Day 22 of the treatment period. Participants, who completed the treatment period, underwent surgery at Week 14.

[ 0 ]

2

[ 0, 0 ]

intervention 1: Capecitabine is available as 50 mg and 500 mg tablets. It will be administered as a 1000mg/m\^2 bid orally on Days 1-14, and at a dose of 825mg/m\^2 bid on Days 22-35 and 43-56. intervention 2: Oxaliplatin is available in vials containing 50 mg or 100 mg. It will be administered as a oxaliplatin 130mg/m\^2/d intravenously on Day 1 and 50mg/m\^2/d on Days 22, 29, 43 and 50 prior to radiotherapy up to Week 9 followed by surgery period.

intervention 1: Capecitabine intervention 2: Oxaliplatin

6

Basel | N/A | Switzerland | 7.57327 | 47.55839 Chur | N/A | Switzerland | 9.53287 | 46.84986 Lucerne | N/A | Switzerland | 8.30635 | 47.05048 Sankt Gallen | N/A | Switzerland | 9.37477 | 47.42391 Zurich | N/A | Switzerland | 8.55 | 47.36667 Zurich | N/A | Switzerland | 8.55 | 47.36667

0

NCT02694718

[ 4 ]

58

RANDOMIZED

CROSSOVER

0TREATMENT

2DOUBLE

false

0ALL

false

A study to evaluate the cholesterol-lowering effects of ezetimibe in participants with primary hypercholesterolemia (high cholesterol) after eating a meal that is high in cholesterol. The primary hypothesis is that treatment with ezetimibe 10 mg/day reduces the cholesterol concentration of the chylomicron-containing Sf≥400 fraction following a cholesterol-enriched test meal.

null

Hypercholesterolemia

Primary Hypercholesterolemia

null

2

arm 1: After a 2-week single- blind placebo run-in, participants will receive ezetimibe 10 mg once daily for 4 weeks and then receive placebo once daily for 4 weeks. arm 2: After a 2-week single- blind placebo run-in, participants will receive placebo once daily for 4 weeks and then receive ezetimibe10 mg once daily for 4 weeks.

[ 0, 0 ]

2

[ 0, 0 ]

intervention 1: None intervention 2: None

intervention 1: ezetimibe intervention 2: Comparator: placebo

0

null

0

NCT00101439

[ 3 ]

131

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

1FEMALE

null

This was a prospective, randomized, Phase II, comparative study with a parallel control for evaluating the efficacy and safety of combined treatment of recombinant human follicle stimulating hormone (r-hFSH) and recombinant human luteinizing hormone (r-hLH). The combined treatment was administered at the middle of the follicular phase in subjects undergoing in-vitro fertilisation (IVF) through intracytoplasmic sperm injection (ICSI) and transfer of embryos (ET).

null

Infertility Ovulation Induction

Reproductive technology, Assisted Recombinant human follicle stimulating hormone (r-hFSH) Recombinant leutinizing hormone (r-hLH) Ovulation induction Infertility

null

2

arm 1: None arm 2: None

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: Subjects will receive subcutaneous injection of recombinant human follicular stimulating hormone (r-hFSH) 300-450 International Units (IU) administered after pituitary desensitization according to the ovarian response with gonadotrophin-releasing hormone agonist (GnRH-a; at a dose of 0.1 milligram per day \[mg/day\]). intervention 2: Subjects will receive subcutaneous injection of recombinant human luteinizing hormone (r-hLH) 150 IU/day until the end of ovarian stimulation.

intervention 1: Recombinant human follicle stimulating hormone (r-hFSH) intervention 2: Recombinant human luteinizing hormone (r-hLH)

1

Vizcaya | N/A | Spain | N/A | N/A

0

NCT01110707

[ 4 ]

20

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

An evaluation of tablet disintegration and absorption and gastric transit of sumatriptan and naproxen sodium from a TREXIMA tablet and eletriptan from a RELPAX 40mg tablet.

null

Migraine Disorders

Combination product, sumatriptan succinate, naproxen sodium, absorption, pharmacokinetics, disintegration, gastric transit, gastric scintigraphy

null

2

arm 1: open-label active drug arm 2: open-label active drug

[ 5, 5 ]

2

[ 0, 0 ]

intervention 1: sumatriptan/naproxen sodium intervention 2: eletriptan tablets

intervention 1: Combination Product (sumatriptan succinate / naproxen sodium) intervention 2: RELPAX(eletriptan) 40mg Tablet

1

Lexington | Kentucky | United States | -84.47772 | 37.98869

0

NCT00385008

[ 5 ]

70

RANDOMIZED

CROSSOVER

0TREATMENT

2DOUBLE

false

0ALL

false

Eligible subjects will be randomized to receive VALTREX 1g or placebo once daily for 60 days in a two-way crossover study with a washout period of 7 days in between.

null

Herpes Labialis

Recurrent Genital Herpes

null

0

null

1

[ 0 ]

intervention 1: valacyclovir

18

0

NCT00306293

[ 5 ]

764

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

null

The primary objective of the study is to assess the clinical efficacy of Rebif® 44 microgram (mcg) three times per week compared with Copaxone® 20 milligram (mg) daily in subjects with relapsing Multiple Sclerosis.

null

Relapsing-remitting Multiple Sclerosis

null

2

arm 1: None arm 2: None

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: Subjects will be administered with Rebif® (Recombinant interferon beta-1a) as subcutaneous (SC) injection at a dose of 44 microgram (mcg) three times weekly (tiw). intervention 2: Subjects will be administered with Copaxone® (Glatiramer acetate) as subcutaneous (SC) injection at a dose of 20 milligram (mg) once daily (qd).

intervention 1: Rebif® intervention 2: Copaxone®

80

1

NCT00078338

[ 4 ]

29

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

1FEMALE

true

The PERCHE trial evaluated the worth of adding adjuvant chemotherapy for premenopausal women with steroid hormone receptor positive early invasive breast cancer who receive ovarian function suppression plus either tamoxifen or exemestane for five years. The use of chemotherapy was determined by randomization. The method of ovarian function suppression (GnRH analogue for five years, surgical oophorectomy or ovarian irradiation) and the choice of tamoxifen or exemestane were determined by the investigator or by randomization in the IBCSG 25-02 TEXT trial \[recommended option\]. The trial was terminated early due to poor accrual.

OBJECTIVES: * Compare ovarian function suppression and tamoxifen or exemestane with vs without adjuvant chemotherapy in premenopausal women with endocrine-responsive resected breast cancer. * Compare the disease-free and overall survival of patients treated with these regimens. * Compare sites of first treatment failure in patients treated with these regimens. * Compare the incidence of second nonbreast malignancies in patients treated with these regimens. * Compare the quality of life, including late side effects of early menopause, of patients treated with these regimens. PLANNED OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, number of positive axillary and/or internal mammary lymph nodes (0 vs 1 or more), method of ovarian function suppression (triptorelin vs oophorectomy vs ovarian irradiation), chemotherapy if randomized to arm II (not containing vs containing an anthracycline or taxane), and endocrine agent (tamoxifen vs exemestane vs selected by subsequent randomization in the TEXT trial). Treatment duration is five years. Quality of life is assessed at baseline, every 6 months for 2 years, and then annually for 4 years. Patients are followed every 3 months for 1 year, every 6 months for 5 years, and then annually thereafter. NOTE: Trial was terminated early due to poor accrual.

Breast Cancer

stage IIIA breast cancer stage I breast cancer stage II breast cancer

null

2

arm 1: Ovarian function suppression (OFS) by triptorelin for 5 years or surgical oophorectomy or ovarian irradiation PLUS tamoxifen (T) or exemestane (E) for 5 years. arm 2: Chemotherapy plus ovarian function suppression (OFS) by triptorelin for 5 years or surgical oophorectomy or ovarian irradiation PLUS tamoxifen (T) or exemestane (E) for 5 years.

[ 0, 0 ]

6

[ 0, 0, 0, 0, 3, 3 ]

intervention 1: Planned duration of chemotherapy: 2 months if an anthracycline is included (e.g., 4 cycles of EC or AC) or 4 months if no anthracycline is given (e.g., 6 cycles of CMF) is recommended. Unless medically contraindicated, an anthracycline-containing regimen using epirubicin should be given. intervention 2: Exemestane 25 mg orally daily for until 5 years from date of randomization, unless relapse or intolerance should occur earlier. intervention 3: Tamoxifen 20 mg orally daily until 5 years from date of randomization, unless relapse or intolerance should occur earlier. intervention 4: Triptorelin (GnRH analogue) 3.75 mg by intramuscular injection every 28 days for 5 years from randomization, unless relapse or intolerance should occur earlier or surgical oophorectomy or ovarian irradiation is subsequently performed. intervention 5: Bilateral surgical oophorectomy via laparotomy or laparoscopy. intervention 6: Bilateral ovarian irradiation.

intervention 1: chemotherapy intervention 2: exemestane intervention 3: tamoxifen intervention 4: triptorelin intervention 5: oophorectomy intervention 6: ovarian irradiation

6

Budapest | N/A | Hungary | 19.04045 | 47.49835 Aviano | N/A | Italy | 12.59472 | 46.07056 Milan | N/A | Italy | 9.18951 | 45.46427 Chur | N/A | Switzerland | 9.53287 | 46.84986 Lausanne | N/A | Switzerland | 6.63282 | 46.516 Sankt Gallen | N/A | Switzerland | 9.37477 | 47.42391

0

NCT00066807

[ 0 ]

300

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

true

The purpose of this study is to determine if opening blocked arteries with heart balloons and stents prevents heart rhythm problems in individuals 3 to 28 days after a heart attack.

BACKGROUND: There is now unequivocal evidence that early coronary reperfusion using either thrombolytics or primary angioplasty results in a long-term mortality reduction among individuals who have had a heart attack. The benefit of early reperfusion (less than 6 hours after the heart attack) was initially attributed to myocardial salvage and the resultant preservation of left ventricular function. However, it is now known that the survival benefit associated with thrombolytic therapy is not consistently associated with a major improvement in left ventricular ejection fraction (LVEF). These observations led to the formulation of the "late open artery hypothesis," which suggests that clinical outcomes can potentially be improved by late reperfusion after a heart attack. Observational clinical studies have suggested that late patency of the infarct-related artery (IRA) after thrombolysis is associated with a survival benefit that is independent of LVEF and therefore cannot be solely explained by salvage of myocardium. Definitive proof of the late open artery hypothesis is currently lacking, however, because previous studies that have evaluated late percutaneous transluminal coronary angioplasty (PTCA) of occluded IRAs after a heart attack have produced conflicting results. These findings led to the organization of the Occluded Artery Trial (OAT), an international, NHLBI-funded, randomized trial of 2,200 participants. OAT is testing the hypothesis that mechanical reperfusion of an occluded IRA with PTCA and percutaneous coronary intervention (PCI) 3 to 28 days after a heart attack in high-risk individuals will reduce mortality, recurrent heart attacks, and hospitalization for class IV congestive heart failure. Enhancement of electrical stability is one of the major mechanisms that has been proposed to explain the association of an open IRA with an improved prognosis independent of myocardial salvage. DESIGN NARRATIVE: This study is an ancillary study of OAT. It will characterize the effects of late PCI of occluded IRAs on the most important and clinically relevant noninvasive markers of vulnerability to malignant ventricular arrhythmias: heart rate variability, T wave variability, and signal-averaged electrocardiography. These analyses will be performed in 300 participants at baseline, 30 days, and 1 year following a heart attack in order to determine the effects of late PCI on the autonomic nervous system, ventricular repolarization, and ventricular conduction abnormalities.

Cardiovascular Diseases Heart Diseases Myocardial Infarction Coronary Disease Arrhythmia Ventricular Fibrillation

Stents, myocardial infarction

null

2

arm 1: Percutaneous Coronary Intervention (PCI) with angioplasty and stenting of the infarct-related artery and optimal medical therapy arm 2: Optimal medical therapy alone

[ 0, 0 ]

2

[ 3, 0 ]

intervention 1: None intervention 2: Guideline-directed drug therapies after MI

intervention 1: PCI intervention 2: Optimal Medical Therapy

1

Stony Brook | New York | United States | -73.14094 | 40.92565

0

NCT00119847

[ 3 ]

116

NON_RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

The purpose of this study is to evaluate the long-term safety of febuxostat, once daily (QD), in maintaining serum urate levels within clinically acceptable levels in subjects with gout.

Uric acid is the end product of purine degradation in humans. Hyperuricemia, a urate concentration in serum exceeding the limit of urate solubility (approximately 7.0 milligrams per deciliter \[mg/dL\]), is a common biochemical abnormality. Aberrations in any of the multiple mechanisms involved in the production and/or excretion of uric acid may increase serum urate concentrations, with persistent hyperuricemia as a marker for extracellular fluid monosodium urate supersaturation. As such, hyperuricemia is a necessary (but often not sufficient) risk factor for monosodium urate crystal deposition in tissues and is the fundamental pathophysiological process underlying the clinical manifestations of gout, which is a chronic disease characterized by urate crystal formation and deposition in joints and bones. Gout may progress from episodic attacks of acute inflammatory arthritis to a disabling chronic disorder characterized by deforming arthropathy; destructive deposits of urate crystals (tophi) in bones, joints, and other organs; structural and functional renal impairment due to interstitial urate crystal deposition; and urinary tract stones composed entirely or in part of uric acid crystals. Management of gout requires chronic treatment aimed at lowering serum urate into a subsaturating range (usually \<6.0 mg/dL) in which crystal formation and deposition are prevented or reversed. Febuxostat (TMX-67) is a non-purine selective xanthine oxidase inhibitor being developed as an orally administered agent for management of hyperuricemia in patients with gout. Subjects who want to participate in this study will have successfully completed study TMX-00-004 (NCT00174967). All participants will initially receive an 80 mg dose. Dose titrations will occur in order to obtain and maintain clinically acceptable serum urate levels.

Gout

Uric acid xanthine oxidase tophi Drug Therapy

null

3

arm 1: None arm 2: None arm 3: None

[ 0, 0, 0 ]

3

[ 0, 0, 0 ]

intervention 1: Febuxostat 40 mg, tablets, orally, once daily, based on serum urate level. intervention 2: Febuxostat 80 mg, tablets, orally, once daily, based on serum urate level. intervention 3: Febuxostat 120 mg, tablets, orally, once daily, based on serum urate level.

intervention 1: Febuxostat intervention 2: Febuxostat intervention 3: Febuxostat

0

null

0

NCT00174941

[ 5 ]

117

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

true

The purpose of this study is to examine whether adjunctive galantamine is effective in the treatment of cognitive impairments in patients with schizophrenia.

Patients with schizophrenia are characterized by a broad range of neurocognitive abnormalities. These include impairments in attention; eye-tracking; visual and verbal memory; working memory; processing speed; and sensory gating, as measured by P50. These impairments are major determinants of poor functional outcome in patients with schizophrenia. Conventional antipsychotics have limited effects on these impairments. Second generation antipsychotics (SGAs) may have modest benefits for cognitive function, but whether this represents a direct cognitive enhancing effect has not been established. Regardless, patients continue to exhibit pronounced cognitive impairments despite adequate new generation antipsychotic treatment. Adjunctive pharmacotherapy may offer a viable approach for the treatment of cognitive impairments. Adjunctive agents can be used to modulate specific neurotransmitter systems that are hypothesized to be involved in the pharmacology of cognitive functions. Acetylcholine acts at muscarinic and nicotinic cholinergic receptors. These receptors are broadly distributed through the brain, including the neocortex, hippocampus, and basal ganglia. Cholinergic mechanisms have been implicated in the regulation of attention, memory, processing speed, and sensory gating processes; processes which are impaired in patients with schizophrenia. Nicotine has previously been shown to improve sensory gating, as measured by P50, and eye-tracking in patients with schizophrenia. The gene for the alpha-7 nicotinic receptor, which is hypothesized to be the nicotinic receptor involved in sensory gating regulation, has also been shown to be linked to schizophrenia. Galantamine (Trade name: Reminyl) is a new FDA-approved selective acetylcholinesterase inhibitor (AChEI), which may also allosterically modulate nicotinic receptors, enhance receptor sensitivity, and increase nicotinic receptor density. Galantamine is marketed by Janssen Research Foundation. In animal models of aging, galantamine enhanced long-term potentiation, ameliorated learning impairments, and elevated the number of nicotinic receptors in the hippocampus and neocortex. In placebo-controlled studies, galantamine has been shown to not only delay deterioration but to improve cognitive function in patients with Alzheimer's disease. There is also preliminary evidence that galantamine may ameliorate positive psychotic symptoms in these patients. AChEIs have not been extensively studied in patients with schizophrenia. We have conducted a 6-week open-labeled pilot study of adjunctive donepezil in patients treated with olanzapine for a minimum of 6 months. Fifteen patients entered the study and 14 patients completed the study. One patient withdrew with a complaint of sedation. The demographic characteristics of the patients who completed the study were: mean (SD) age: 43.1 6.6; 71% male; 78% caucasian; and mean (SD) duration of illness: 24.7 7.2. The mean (SD) olanzapine dose was 25.7 11.9 mg/day. Two patients were receiving benzodiazepines, two were receiving antidepressants, and one was receiving valproic acid. Donepezil resulted in a modest improvement in sensory gating. Nine patients had abnormal P50 at baseline, which normalized for five patients following treatment. Donepezil had a more pronounced effect on neuropsychological test performance, with large and significant effect sizes observed for the visual memory (effect size (ES)=.57) and manual dexterity (ES=.93) measures. There were moderate improvements on the verbal recall memory (ES=0.46) and processing speed (ES=0.48) measures. The only cognitive measure that did not change with treatment was a measure of attention. There were no significant changes in either positive symptom (mean (SD), baseline: 9.3 3.8; week 6: 8.2 3.8; t=-1.55, df=14, p=.14) or negative symptom (mean(SD), baseline: 29.7 10.9; week 6: 30.0 12.6; t=0.15, df=14, p=.88) measures. The results of this study suggest that adjunctive AChEIs may be an effective treatment for cognitive impairments in patients with schizophrenia. Moderate to large effect size improvements were observed on verbal and visual memory, processing speed, and manual dexterity measures. Patients exhibited a greater than 20% increase in suppression of their P50 response to repeated auditory stimuli. There was no effect of donepezil on a measure of attention. Donepezil was well tolerated; only one patient dropped out of the study and nine of the remaining subjects chose to continue on the drug beyond the protocol. An important aspect of the study was that cognitive function improvement occurred in the context of concurrent olanzapine treatment, which is reported to improve P50 and cognitive function (Purdon et al, 2000; Light et al, 2000). Thus, donepezil was able to further enhance cognitive function in patients who may have already benefitted from olanzapine treatment. The primary study objectives are: 1. To examine whether adjunctive galantamine is more effective than placebo for neuropsychological measures of attention, verbal and visual memory, working memory, processing speed, and manual dexterity. 2. To examine whether adjunctive galantamine is more effective than placebo for evoked potential measures of sensory gating (i.e., P50) and attention (i.e., P300 and Gamma Band Response (GBR)) and smooth pursuit eye movement. We hypothesize that galantamine will have a significant benefit for these cognitive behaviors based on the role of acetylcholine in the regulation of these behaviors; our pilot study with donepezil which demonstrated that AChEIs may have a beneficial effect for verbal and visual memory, processing speed, and manual dexterity; and previous studies that have shown acute nicotine administration to normalize P50 and eye-tracking in patients with schizophrenia. The secondary study objectives are: 1. To examine whether adjunctive galantamine is more effective than placebo for positive symptoms and negative symptom measures. 2. To examine whether adjunctive galantamine is more likely than placebo to cause nausea, vomiting, diarrhea, anorexia, weight loss, or dizziness, i.e., common side effects associated with AChEI treatment. 3. To examine whether galantamine is more likely than placebo to cause an increase in either extrapyramidal symptoms or dyskinetic movements. 4. To examine whether galantamine is more effective than placebo for reducing smoking behavior. We hypothesize that there will not be a significant difference between galantamine and placebo for positive and negative symptoms based on our donepezil pilot study. We hypothesize that galantamine will be associated with an increased incidence of AChEI associated side effects. We hypothesize that there will not be a significant difference between galantamine and placebo for either extrapyramidal symptoms or dyskinetic movements. Study Design and Methods: The proposed study is a randomized, parallel group, double-blind comparison of adjunctive galantamine or placebo. The sample will consist of 90 clinically stable inpatients and outpatients with DSM-IV schizophrenia or schizoaffective disorder. There will be a 2-week stabilization phase, a 12-week treatment phase, and an optional 6-month open-label phase. In the 2-week stabilization phase, patients will undergo baseline symptom, medical, safety, antipsychotic level, and neurocognitive assessments. In the 12-week treatment phase, patients will be randomized to either galantamine or placebo. Patients will receive biweekly symptom, side effect, and vital sign assessments. At the end of study (12 weeks), laboratory tests, EKG, antipsychotic levels, and neurocognitive assessments will be repeated. Patients will be monitored at the 3-month and 6-month points of the open-labeled phase, during which they will receive laboratory tests, EKG, and side effect review. At the end of the 6-month open-labeled phase, patients will again be asked to participate in symptom ratings and neuropsychological tests.

Schizophrenia Schizoaffective Disorder

schizophrenia acetylcholine cognitive impairments attention processing speed sensory gating eye-tracking

null

2

arm 1: galantamine, 24mgs, p.o., qday arm 2: placebo, 3 tablets, p.o., qday

[ 0, 2 ]

1

[ 0 ]

intervention 1: see arm/group description

intervention 1: galantamine

1

Baltimore | Maryland | United States | -76.61219 | 39.29038

0

NCT00176423

[ 0 ]

15

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

null

The purpose of this study is to collect and evaluate information on the use of Depakote Extended Release (ER) and Depacon Intravenous (IV) in patients with cluster headaches. Patients who are currently in a cluster cycle will be treated with 2 consecutive days of IV Depacon followed by oral Depakote ER. Patients will receive a total of 1,000mg of Depacon and 1,000mg of Depakote ER each day. Patients may have a 3rd day of IV Depacon followed by oral Depakote ER if the primary investigator believes it to be beneficial. The patient is then sent home on oral Depakote ER. The dose of Depakote ER can range from 500mg to 2,000mg this dose is to be determined by the primary investigator. The patient will continue the oral Depakote ER until the end of their cluster cycle or for a maximum of 6 weeks, which ever comes first.

This study will consist of four visits (3 visits if the screening visit and first treatment visit are on the same day). Screening Visit: The screening visit can be performed either before an active cluster period or once the cluster period has already started. If the subject agrees to participate, the study doctor will determine if they are eligible for this study. The subject will be asked about their headache history, and medical history including all medications they are currently taking. A brief physical examination and neurologic examination will be performed and vital signs (pulse and blood pressure) will be measured. If the subject is a woman who is capable of bearing children, they will be asked to provide a urine sample for a routine pregnancy test. A blood sample (approximately 2 teaspoons) will also be obtained. Blood samples will be taken for a liver function test (LFT), complete blood count (CBC) with differential, chemistry profile, prothrombin time (PT) and partial thromboplastin time (PTT).If the screening visit is the same day as the first treatment visit, this blood work will be sent for immediate analysis. The results must be reviewed and approved by the study physician prior to the subject being administered study medication. Treatment Visit One: If the subject does not undergo treatment at the screening visit because they are not in an active cluster period, the subject will be asked to contact the site once their next cluster period begins. Subjects will be scheduled to come for their first treatment visit as soon as possible. If the screening visit is not the same day as the first treatment visit, the study physician and or delegated research staff will re-explain the informed consent, ask the subject to re-read the informed consent and verbally re-confirm their agreement to participate in this trial. The research staff will then determine whether the subject continues to qualify for the research trial. They will ask the subject about any changes in their medications since their last visit and/or any changes in their medical conditions since their last visit. Vital signs will be measured and if the subject is a woman of childbearing potential a urine sample will be obtained for routine pregnancy testing. A brief physical examination and neurologic examination will be performed by the study physician. The subject will be given a diary to take home with instructions on how to complete it. The subject will be scheduled to return to the study office the next day. Once all of the above procedures have been completed, the research staff will then ask the subject to lie down in an exam room. They research nurse or study physician will then administer one of the study medications (Depacon) through an IV placed in their arm. Subjects will receive 1000mg of Depacon IV. This medication will be infused (administered) over a five minute period. The subjects' vital signs will be measured at 3 minutes, 5 minutes and 15 minutes after the medication has been completely administered. The subject will remain in the study office for one hour for observation. Subjects will be closely monitored and repeatedly queried for the development of adverse events. Appropriate intervention and follow-up will be applied as deemed necessary by the investigator. Prior to leaving the office, the research nurse or study physician will give the subject an oral dose of the second study medication, 1000mg of Depakote ER. Treatment Visit Two: The subject will return to the study office the next day for their second treatment visit. The study staff will review the subject's diary and record their vital signs. The subject's take home diary will be re-dispensed. The subject will then undergo the same infusion procedure as in their first treatment visit. Subjects will again receive a total of 1000mg of Depacon IV. Subjects will be closely monitored and repeatedly queried for the development of adverse events. Appropriate intervention and follow-up will be applied as deemed necessary by the investigator. Prior to leaving the office, the research nurse or study physician will give the subject an oral dose of the second study medication, 1000mg of Depakote ER. The subject may or may not be asked to return the next day for a third treatment day depending on the study physicians' review of their response to study treatment. If it is determined that the subject does not need to return for a third treatment day, a blood sample will be obtained from a vein in their arm. The subject will also be given a take home supply of the oral study drug Depakote ER with instructions. The subject will be scheduled to return to the study office in 6 weeks OR when their current cluster cycle ends, whichever comes first. The research staff will contact the subject bi-weekly to see how they are doing and to confirm that they are taking your study drug appropriately. The research staff will also ask the subject if they have had any unwanted experiences since their last contact with the site. The subject will be instructed to call the study site should they have any questions or have any unwanted experiences. Treatment Visit Three: If the study physician determines that the subject should return for a third treatment day, the subject will return to the study office the day after their second treatment visit. The same infusion procedures will be performed. The study staff will review the subject's diary and record their vital signs. A blood sample (2 teaspoons) will be obtained from a vein in their arm. Prior to leaving the office, the research nurse or study physician will give the subject an oral dose of the second study medication, Depakote ER. The subject will be given a take home supply of the oral study drug Depakote ER with instructions. Subjects will be instructed to take 2000mg of Depakote ER once a day. The subject will be scheduled to return to the study office in 6 weeks OR when their current cluster cycle ends, whichever comes first. The research staff will contact the subject bi-weekly to see how they are doing and to confirm that they are taking your study drug appropriately. The research staff will also ask whether or not the subject had any unusual symptoms, or out of the ordinary experiences since their last contact with the site. The subject will be instructed to call the study site should they have any questions or have any unwanted experiences. Final Visit: The final visit to the study office will occur either 6 weeks after the subjects last treatment visit OR when the subjects current cluster cycle ends, whichever comes first. At this visit, the study staff will collect and review the subject's diary as well as any unused study medication. The subject will be asked about any changes in medications and/ or medical conditions since their last contact with the site. The subject will also be asked about any unusual symptoms, or out of the ordinary experiences since their last contact with the site. The subject will be asked to report how they felt they responded to the study medication. The subject's vital signs will be measured and a blood sample (2 teaspoons) will be obtained from a vein in their arm.

Cluster Headache

null

1

arm 1: Subjects will be treated in this single arm study with 2 consecutive days of IV Depacon followed by oral Depakote ER for a total of 1000 mg of Depacon and 1000 mg of Depakote ER each day.

[ 0 ]

1

[ 0 ]

intervention 1: None

intervention 1: Depacon IV and Depakote ER

1

Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238

0

NCT00203242

[ 3 ]

60

NON_RANDOMIZED

FACTORIAL

0TREATMENT

0NONE

false

0ALL

null

The purpose of this study is to evaluate three dose levels of a combination tablet and a fixed dose granule formulation of pyronaridine and artesunate (PA) for the treatment of acute uncomplicated falciparum malaria in children.

This is a Phase II, open-label, sequential-group, dose-escalation, single-centre study to study pharmacokinetics, bioavailability comparison of tablets vs. granules, and safety/tolerability of PA in paediatric patients with acute symptomatic uncomplicated P. falciparum malaria. The study population will include 60 patients, comprising male and female children recruited from a single study site located in the endemic region of Gabon. Patients will be assigned sequentially to 1 of 4 treatment groups (15 per group): Group A (Tablets) PA (48 mg + 16 mg), Group B (Tablets) PA (72 mg + 24 mg), Group C (Tablets) PA (96 mg + 32 mg), Group D (Granules) PA (60 mg + 20 mg). Oral tablets will be taken once daily for 3 consecutive days (Days 0, 1 and 2). The dose given to each patient depends on the dosing cohort group and the patient's body weight. Each patient will attend the study site for screening and baseline procedures, as well as receipt of the first dose of study drug on Day 0 (Visit 1, baseline). Patients will be hospitalised for the first 72 hours and remain near the study site for the entire duration of the study. The patients will return to the study site for all scheduled follow-up visits until discharge on Day 42. The primary efficacy end point for the study is the incidence of patients with PCR-corrected adequate clinical and parasitological response (ACPR) on Day 28. In the case of adverse events reported and unresolved at Day 42, patients will be followed up for a further 30 days, or until resolution of the event.

Uncomplicated Plasmodium Falciparum Malaria

malaria P. falciparum artemisinin based combination therapy (ACT) antimalarial pyronaridine artesunate (Pyramax)

null

4

arm 1: Pyronaridine artesunate 6:2 mg/kg. The tablet strength is 48:16 mg oral PA, with the number of tablets depending on body weight. arm 2: Pyronaridine artesunate 9:3 mg/kg. The tablet strength is 72:24 mg oral PA, with the number of tablets depending on body weight. arm 3: Pyronaridine artesunate 12:4 mg/kg. The tablet strength is 96:32 mg oral PA, with the number of tablets depending on body weight. arm 4: Pyronaridine artesunate 9:3 mg/kg. The sachet of granules strength is 60:20 mg PA, with the number of sachets depending on body weight, and is administered as a suspension with water.

[ 0, 0, 0, 0 ]

1

[ 0 ]

intervention 1: Once a day for 3 days

intervention 1: Pyronaridine-Artesunate

1

Lambaréné | N/A | Gabon | 10.24055 | -0.7001

0

NCT00331136

[ 5 ]

1,452

RANDOMIZED

PARALLEL

1PREVENTION

1SINGLE

false

0ALL

true

Trachoma, an ocular infection caused by C. trachomatis, is the second leading cause of blindness worldwide.Years of repeated infection with C. trachomatis cause the eyelid to scar and contract and ultimately to rotate inward such that eyelashes rub against the eyeball and abrade the cornea (trichiasis). The World Health Organization (WHO) has endorsed a multi-faceted strategy to combat trachoma, which includes surgery to correct trichiasis. Despite this encouraging news, under the best of circumstances the recurrence rate of trichiasis following surgery is disappointingly high. The objective of our project is to conduct a randomized, controlled clinical trial of post-surgical antibiotic treatment, comparing oral azithromycin to topical tetracycline, for trichiasis surgical patients in Ethiopia with the goal of determining the impact of treatment on rates of trichiasis recurrence at one and two years.

A randomized clinical trial of the effectiveness of a single dose of azithromycin compared to 6 weeks of topical tetracycline, and the added benefit of family-based azithromycin treatment, in preventing recurrence of trichiasis following surgery is proposed. This will provide the evidence base to inform and change the global public health policy and the donation program policy, regarding post-surgical treatment for trichiasis patients and possibly their families. The investigators will determine the impact of three treatment strategies following trichiasis surgery on the rate of trichiasis recurrence in the operated eye at six months and one year. A randomized clinical trial of 1425 trichiasis surgical patients will be conducted in Sodo,Ethiopia. The first group (Control Group) will receive topical tetracycline following surgery; the second group (Intervention Patient Group) will receive oral azithromycin; the third group (Intervention Family Group) will receive oral azithromycin, and all family members resident in the patient's household will also receive oral azithromycin. Data will be collected at baseline (pre-surgery) on ocular status and infection status. Data will be collected at the time of surgery on surgery-related variables and surgical and post-operative complications. Additional data will be collected on any surgical complications and early recurrence at the two-week visit when sutures will be removed. A follow up visit at two months will include data collection on recurrence and presence of ocular infection. Evaluations for trichiasis recurrence will occur again at six months and at one year post-surgery. The latter visit will also include data collection on presence of ocular infection in the surgical case, and ocular infection in household members. Evaluation of the risk of recurrence at six months and one, two, and three years within each group will be completed to determine the benefit of using azithromycin compared to topical tetracycline, and the added benefit of family-based treatment.

Trichiasis

trichiasis azithromycin trichiasis surgery topical tetracycline

null

3

arm 1: topical tetracycline arm 2: oral azithromycin, single 1g dose to subject arm 3: single oral azithromycin dose to subject and immediate family members

[ 1, 1, 1 ]

2

[ 0, 0 ]

intervention 1: oral antibiotic intervention 2: None

intervention 1: azithromycin intervention 2: topical tetracycline

1

Baltimore | Maryland | United States | -76.61219 | 39.29038

0

NCT00347776

[ 3 ]

449

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

The purpose of this study is to evaluate the safety, efficacy, and tolerability of azilsartan medoxomil, once daily (QD), in individuals with hypertension.

Hypertension affects approximately 50 million individuals in the United States. As the population ages, the prevalence of hypertension will continue to increase if broad and effective preventive measures are not implemented. Data from the Framingham Heart study suggest that the lifetime risk of developing hypertension among 55- to 65-year-old individuals is greater than 90%. According to the World Health Organization, hypertension is the most common attributable cause of preventable death in developed nations, as uncontrolled hypertension greatly increases the risk of cardiovascular disease, cerebrovascular disease, and renal failure. Despite the availability of hypertension treatments, hypertension remains inadequately controlled; only about one third of patients continue to maintain control successfully. To help address these matters, the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure proposes a more aggressive intervention to hypertension management with more potent antihypertensive agents and combination therapy. Takeda Global Research \& Development Center, Inc. is developing TAK-491 (azilsartan medoxomil) to treat mild to moderate essential hypertension. Azilsartan medoxomil is a prodrug that is rapidly hydrolyzed to the activity moiety, azilsartan, which is an angiotensin II type 1 receptor antagonist. This study is proposed to evaluate the efficacy, safety and tolerability of multiple doses of azilsartan medoxomil at five dose levels in subjects with mild to moderate uncomplicated essential hypertension. Individuals who want to participate in this study will be required to provide written informed consent. Study participation is anticipated to be about 11 weeks. Multiple procedures will occur at each visit which may include fasting, blood collection, urine collection, vital signs including sitting and standing blood pressure and pulse, body height and weight, physical examinations, electrocardiogram Outside of the study center, participants will be required to wear an ambulatory blood pressure monitoring device at approximately 24 and 36 hour intervals.

Hypertension

hypertension blood pressure diastolic blood pressure drug therapy

null

7

arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None arm 7: None

[ 0, 0, 0, 0, 0, 1, 2 ]

7

[ 0, 0, 0, 0, 0, 0, 0 ]

intervention 1: Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks. intervention 2: Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks. intervention 3: Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks. intervention 4: Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks. intervention 5: Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks. intervention 6: Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks. intervention 7: Matching placebo tablets, orally, once daily for up to 8 weeks.

intervention 1: Azilsartan Medoxomil intervention 2: Azilsartan Medoxomil intervention 3: Azilsartan Medoxomil intervention 4: Azilsartan Medoxomil intervention 5: Azilsartan Medoxomil intervention 6: Olmesartan intervention 7: Placebo

54

0

NCT00362115

[ 3 ]

34

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

null

1.Study rationale:There is no standard regimen for the advanced and/or metastatic gastric cancer patients who relapsed after adjuvant chemotherapy or failed to first systemic chemotherapy. 2.Primary Objectives:To evaluate overall response rate according to the Response Evaluation Criteria in Solid Tumors criteria and To investigate time to response 3.Design:single-center, Open label, Phase II study. docetaxel 75mg/m2 administered on day 1 as intravenously combined with intravenous Epirubicin 60mg/m2 given day 2 every 3 weeks. 4.Primary endpoints: 1. Efficacy:overall response rate according to the Response Evaluation Criteria in Solid Tumors criteria, time to response, duration of response, and time to treatment failure. 2. Safety-Adverse events and laboratory tests, graded according to the NCI Common Toxicity Criteria for Adverse Effects (version 3.0).

null

Stomach Neoplasms

null

1

arm 1: salvage docetaxel and epirubicin

[ 0 ]

1

[ 0 ]

intervention 1: None

intervention 1: Docetaxel and epirubicin

1

Seoul | N/A | South Korea | 126.9784 | 37.566

0

NCT00375999

[ 3 ]

44

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

The main objective of this phase 2a proof-of-concept trial is to assess the efficacy of rotigotine nasal spray in ascending doses in subjects with idiopathic Restless Legs Syndrome.

Each patient of the placebo and rotigotine group performed an Eligibility Assessment, as well 4 treatment days at which subjects performed a repeated 'Suggested Immobilization Test' (SIT) during a 30min pre-dose and a 4 hours post-dose period. During these periods the severity of RLS symptoms in the legs was assessed by the subject using a numeric symptom severity scale. In addition the leg movements were measured by actigraphy to assess the Periodic Leg Movement Index during Wakefulness (PLMWI, PLM per hour). Subjects applied a single dose of treatment on each treatment day (placebo nasal spray or rotigotine nasal spray in 3 ascending doses).

Restless Legs Syndrome

Rotigotine Rotigotine nasal spray Efficacy, safety and tolerability Restless Legs Syndrome

null

2

arm 1: Subjects receiving a single dose of placebo nasal spray on all 4 treatment days arm 2: Subjects receiving doses of placebo nasal spray on Day 1 or Day 2, Rotigotine nasal spray 62µg on Day 1 or Day 2, Rotigotine nasal spray 124µg on Day 3, and Rotigotine nasal spray 247µg on Day 4

[ 2, 0 ]

2

[ 0, 10 ]

intervention 1: Daily single dose of 62µg, 124µg, and 247µg rotigotine delivered as single puff of nasal spray solution intervention 2: Daily single dose of placebo delivered as single puff of nasal spray solution

intervention 1: Rotigotine Nasal Spray intervention 2: Placebo Nasal Spray

1

Monheim | N/A | Germany | 10.85834 | 48.84389

0

NCT00389831

[ 4 ]

389

RANDOMIZED

PARALLEL

1PREVENTION

2DOUBLE

true

0ALL

false

Although pyridoxine has been used empirically for the prevention of capecitabine associated hand-foot syndrome (HFS), its efficacy needs to be demonstrated in prospective controlled trials. The investigators therefore performed a prospective randomized double-blind study to determine whether pyridoxine 200 mg/day can prevent the development of HFS when given concurrently with capecitabine. The investigators also tested the ability of pyridoxine to treat primary occurrence of grade 2-3 HFS.

Although pyridoxine has been used empirically for the prevention of capecitabine associated HFS, its efficacy needs to be demonstrated in prospective controlled trials. We estimated that the HFS rate with placebo and pyridoxine would be 0.35 and 0.18, respectively, and we therefore calculated that a sample size of 345 patients would be necessary to detect these hazard rates with an 80% power (β=0.2) and two-sided significance level of α=0.05. We assumed a follow up loss rate of 10%, thus requiring 380 patients to be randomized. Chemotherapy-naive patients with gastrointestinal tract cancers who were scheduled for capecitabine-containing chemotherapy were assigned to receive oral pyridoxine or placebo in randomized double-blind placebo controlled study. Pyridoxine 100 mg b.i.d was prescribed to the patients in the pyridoxine group, identical placebo 100 mg b.i.d was prescribed in the placebo group by the closed envelop randomization. Patients were stratified by chemotherapy regimen: capecitabine alone (X), capecitabine and cisplatin (XP), or docetaxel, capecitabine, and cisplatin (DXP). Patients were observed until NCI CTC grade 2 or 3 HFS developed or capecitabine-containing chemotherapy ended. Patients in the placebo group who developed grade 2 or 3 HFS were randomized to receive pyridoxine or placebo for the next chemotherapy cycle to determine whether pyridoxine could improve HFS, and the same treatment was continued for 2 chemotherapy cycles.

Hand-foot Syndrome

hand-foot syndrome capecitabine pyridoxine prevention

null

2

arm 1: one tablet twice per day, which is identical to pyridoxine arm 2: 100 mg twice per day

[ 2, 0 ]

2

[ 0, 0 ]

intervention 1: 100mg BID/daily, Per oral intervention 2: placebo 100mg BID/daily, Per oral

intervention 1: Pyridoxine intervention 2: Placebo

0

null

0

NCT00446147

[ 3 ]

208

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

false

The objectives of this study are to evaluate the efficacy, tolerability and pharmacokinetics of 2 doses of MAP0010 (Unit Dose Budesonide) in asthmatic children/adolescents.

null

Asthma

null

3

arm 1: a single dose of MAP0010 low dose delivered by nebulization twice daily for 6 weeks arm 2: a single dose of MAP0010 high dose delivered by nebulization twice daily for 6 weeks arm 3: Placebo delivered by nebulization twice daily for 6 weeks

[ 0, 0, 2 ]

3

[ 0, 0, 0 ]

intervention 1: a single dose of MAP0010 low dose delivered by nebulization twice daily for 6 weeks intervention 2: a single dose of MAP0010 high dose delivered by nebulization twice daily for 6 weeks intervention 3: Placebo delivered by nebulization twice daily for 6 weeks

intervention 1: MAP0010 low dose intervention 2: MAP0010 high dose intervention 3: Placebo

1

San Diego | California | United States | -117.16472 | 32.71571

0

NCT00697801

[ 2 ]

13

RANDOMIZED

CROSSOVER

2DIAGNOSTIC

2DOUBLE

false

0ALL

null

This study will qualify a functional model that can measure central blood pressure and vascular compliance effects through noninvasive means.

null

Hypertension

null

5

arm 1: losartan 100 mg arm 2: ISMN 60 mg arm 3: losartan 100 mg + ISMN 15 mg arm 4: losartan 100 mg + ISMN 60 mg arm 5: Placebo

[ 1, 1, 1, 1, 2 ]

5

[ 0, 0, 0, 0, 0 ]

intervention 1: Single dose losartan 100 mg in one of five treatment periods intervention 2: Single dose ISMN 60 mg in one of five treatment periods intervention 3: Single dose losartan 100 mg and ISMN 15 mg in one of five treatment periods intervention 4: Single dose losartan 100 mg and ISMN 60 mg in one of five treatment periods intervention 5: Single dose placebo only in one of five treatment periods

intervention 1: losartan potassium intervention 2: Comparator: isosorbide mononitrate (ISMN) intervention 3: Comparator: losartan + ISMN intervention 4: Comparator: losartan + ISMN intervention 5: Comparator: Placebo

0

null

0

NCT00943852

[ 3 ]

76

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

2MALE

false

The primary objective of this study was to determine the appropriate dose of SKY0402 for the management of postoperative pain following inguinal hernia repair. This study evaluated the safety, efficacy, and pharmacokinetics of SKY0402 compared with a 100 mg dose of bupivacaine HCl for the treatment of postoperative pain in subjects undergoing inguinal hernia repair. Study drug was administered by surgical wound infiltration at the end of the hernia repair procedure.

SKY0402 was administered in a dose escalating/de-escalating fashion, with a low starting dose in Cohort 1 that was to be increased or decreased in subsequent cohorts based on safety and analgesic effects. The decision to proceed to the next cohort (i.e., increase or decrease the dose) was made by a Cohort Data Review Committee following a review of the data from the previous cohort. Subjects were randomized to receive either SKY0402 or bupivacaine HCl at a ratio of 1:1 in Cohort 1 and at a ratio of 3:1 in subsequent cohorts. The dose of bupivacaine HCl (100 mg) remained constant for all cohorts.

Inguinal Hernia

Postoperative pain Analgesia

null

2

arm 1: (e.g., Marcaine with epinephrine 1:200,000) is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402 arm 2: Low dose, low-mid dose, mid-dose, and high dose

[ 1, 1 ]

2

[ 0, 0 ]

intervention 1: Single dose of SKY0402 administered locally into the surgical wound. intervention 2: Single dose of bupivacaine HCl (100 mg) administered locally into the surgical wound.

intervention 1: SKY0402 intervention 2: Bupivacaine HCl

0

null

0

NCT01203644

[ 3 ]

58

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

The primary objective of this study was to determine the appropriate dose of SKY0402 administered as a nerve block for the management of postoperative pain following bunionectomy.

This Phase 2, multicenter, randomized, double blind, dose escalating/de-escalating study evaluated the safety, efficacy, and pharmacokinetics of a single dose of SKY0402 compared to a single 125 mg dose of bupivacaine HCl for the treatment of postoperative pain in subjects undergoing bunionectomy. Up to 88 subjects were to be randomized in five consecutive cohorts. The dose of bupivacaine HCl (125 mg) was to remain constant for all cohorts. After completion of Cohort 1, the decision to increase or decrease the dose of SKY0402 was made by a Cohort Data Review Committee following a review of pharmacokinetic, safety, and selected efficacy data from the previous cohort. Study drug was to be administered as an ankle block, with or without a tourniquet, between 1 hour before the induction of general anesthesia and 20 minutes before the end of general anesthesia. The ankle block procedure consisted of five injections via three skin entries targeting the following nerves: posterior tibial, sural, deep peroneal, superficial peroneal, and saphenous. The use of intravenous fentanyl during general anesthesia was permitted, but was not to exceed 250 micrograms. The intraoperative use of morphine was prohibited. Postoperatively, subjects had access to both opioid and non-opioid supplemental pain medication under general guidelines. Blood samples for the determination of plasma bupivacaine concentrations were obtained at Baseline and at specified time points through 96 hours.

Postoperative Pain

Postoperative Pain Bunionectomy Analgesia

null

2

arm 1: Low-dose (175 mg), low-mid dose( 225 mg), and mid-dose (350 mg) arm 2: Marcaine with epinephrine 1:200,000 is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402

[ 1, 1 ]

2

[ 0, 0 ]

intervention 1: Single dose of SKY0402 administered as a nerve block intervention 2: Single dose of 125 mg administered as a nerve block

intervention 1: SKY0402 intervention 2: Bupivacaine HCl

0

null

0

NCT01206595

[ 3 ]

33

RANDOMIZED

CROSSOVER

0TREATMENT

4QUADRUPLE

false

2MALE

true

This study was conceived in order to explain what the investigators previously observed suggesting that lisinopril, a drug normally used to treat patients with high blood pressure and heart failure, may be effective in treating infertile men with low sperm count. The investigators hypothesized, therefore, that the drug will not only improve sperm quantity and quality but also increase the fertility in such patients. The investigators first of all reviewed the results of previously published investigations and found out that there was only a few previous studies done in humans.with this class of drugs. Besides, the methods used in conducting most of those studies have been so faulted that the results cannot be trusted to be showing the true picture. The investigators looked at the various faults pointed out with respect to the their design and conduct and took care of them while designing the investigators own study. This was an attempt to provide more credible answers to the question of whether lisinopril, and possibly other drugs of similar mode of action, can be useful in rectifying the problem of infertility caused by low sperm count and , if so, whether it will be safe to use it in people who do not have high blood pressure or heart failure. In order to achieve this the investigators studied 33 patients with sperm of low cell concentration, low percentage of motile cells and high percentage of abnormal cells from no known cause. The patients were randomly allocated to receive either lisinopril 2.5mg daily (17 patients) or daily placebo (16 patients)and their sperm characteristics were examined at intervals, starting from the beginning of the study until when it ended 282 weeks later. The patients were also monitored for adverse events throughout the period. The data form all the patients that took part in the random allocation of treatments at the beginning of the study were included in the analysis that followed, irrespective of whether they completed the study or not.

Introduction. Infertility constitutes the cause for about 16.6% of patients seeking consultations at the primary healthcare level. Male factor infertility accounts for about 50% of all infertility problems. Of this percentage seminal fluid abnormality of unknown cause is common, occurring in up to 60% of males with unexplained, this type of infertility. Although some subjects with seminal fluid defects have fathered children those with infertility have long posed a major therapeutic challenge. The rationale for using the various hormonal and non-hormonal drugs currently available is, at best, empirical as most of the efficacy trials conducted yielded conflicting results. Although assisted fertilization techniques have now increased the number of therapeutic options available to couples with infertility problems there is still a very serious limitation in the access to the new technology, especially in low-income countries. Besides, there are additional concerns regarding the possible untoward effects. These lingering problems underscore the need for continuing to search for other effective treatment options that will not only be cheaper and more accessible but also less complicated and non-invasive. The current study was occasioned by our previous, independent observations (albeit fortuitous) of normalization of seminal fluid parameters as well as spouse pregnancies in two men with long-standing, idiopathic azoospermia. The common factor between the two men was treatment with low-dose (2.5mg per day) Lisinopril, an angiotensin converting enzyme inhibitor or ACEI prescribed for the concomitant hypertension. A review of the available literature on the efficacy studies of various types of angiotensin converting enzyme inhibitors on sperm count and quality revealed a near-consistent finding of improvement in animal studies. However, methodological flaws have rendered the results in the very scanty human studies extremely difficult to interpret. The current study design was intentionally rigorous; efforts having been consciously made to control for most known confounding factors as far as was possible. Methods. The study was conducted at the University of Nigeria Teaching Hospital, Enugu. A prior approval of the detailed study protocol was obtained from the Ethics Committee of the same hospital. Each of the patients gave informed consent before enrollment into the study. The investigation was a longitudinal, randomized, double-blind and placebo-controlled clinical trial with a crossover design. The subjects for this investigation were selected from a volunteer pool of male patients attending the fertility clinic of University of Nigeria Teaching Hospital, Enugu. At the time of enrollment each subject was given explicit information about the study with respect to the intention, the expectations from him, the procedure, the planned duration of the investigation, and the potential adverse reactions that could occur from the intended medication. The recruitment of patients took place from March 1998 to September 2001 while the actual study lasted for five years, from January 2002 to December 2006. In strict compliance with the protocol requirement all the participants entered the study within 7 days of starting the onset and they were being followed up concurrently. Throughout the period of the clinical trial the patients mandated to continue their different "background" fertility medications in the same doses as they were being prescribed by their attending fertility physicians. The rationale for this was to avoid the unethical situation whereby a group taking placebo would be denied medication. Conceited efforts were made to exclude subjects with any background medication that had a documented interaction with lisinopril. The apparent superfluity of combining a crossover design (which provides for a within-subjects control) with a separate (between-subjects) control was deliberate. That was done in an effort to control, in one swoop, for two potentially confounding factors; viz., the possible effect on the study out-come of the concurrent background medications, and the possible event of a random, seasonal variation in human seminal fluid characteristics. Throughout the whole period of the study the investigators kept in close touch with the patients by phone calls in order to continually motivate them, remind them of scheduled appointment dates, monitor compliance and detect any possible incidence of adverse drug effect. Assessment of compliance to the medications: Compliance to the medications was monitored by a combination of oral interviews and physical inspection of medication containers for pill counting. These were done at every scheduled visit, through sporadic phone calls and by unscheduled home visits. The level of compliance of each patient was expressed in percent (%) and calculated as the actual number of doses taken/the expected number of doses multiplied by 100 for the period under consideration. Adverse events monitoring: The patients were encouraged to report every event promptly by phone to one of the authors (NOG), no matter however minor and not minding whether related to lisinopril or not. Entries were promptly made and then one of the physicians in the team was detailed to make proper assessment of every reported case and make recommendations with respect to further management and/or the need or otherwise for withdrawal of the patient from the trial. Medical interventions, where needed, were given without any cost to the patients. In addition, the serum potassium concentrations and blood pressures (supine and erect) were measured in every patient at each of the scheduled visits in furtherance of the adverse events monitoring. Clinical measurements: Blood pressure measurements were done with mercury sphygmomanometers fitted with adult-size cuffs (Accoson, England) while korotcoffs I and V were used for systolic and diastolic blood pressures respectively. This was because these had given more concordant results among the team members than the traditional I and IV Korotcoffs. The mean arterial blood pressure (MAP) of each patient was calculated using the conventional formula; MAP = \[(2 x diastolic) + systolic\] divided by 3. Laboratory measurements: Seminal fluid for analysis was each time collected by self-masturbation in a room close to the laboratory and submitted promptly to the analysts. The collected semen specimens were incubated at 37 degrees Centigrade and allowed to stand for 1 hour in order to thaw. The pipette method was used for the ejaculate volume while microscopic methods were used for the total sperm cell count, the percentage of sperm cell motility and the percentage of abnormal sperm cell morphology in accordance with the World Health Organization (WHO) guidelines. Serum potassium levels were estimated using the flame photo-metric method as described by Davidson and Henry. The latter was a safeguard against hyperkalemia, a well documented, severe side effect of ACEI therapy. Statistical analysis: The statistical analysis was done with the Statistical Package for the Social Sciences version 16 (SPSS - 16) software. All the data analyses were performed on the basis of the intention-to-treat in which last observations after the baseline were carried forward to end point. Prior to the analysis all the parameter data were examined for distributional patterns using the Shapiro-Wilk Normality test. All the seminal fluid data as well as the serum potassium values were found to be skewed and so were normalized with logarithmic transformations. Two-group comparisons were performed using the unpaired Student's t-tests while proportions were compared using the Fisher's Exact tests. The data from longitudinally measured out-come parameters were analyzed using two-way repeated measures (mixed model) analysis of variance (mixed model ANOVA). Bonferroni's post-hoc multiple comparison tests were run wherever a statistically significant difference was found (at p \< 0.05) in either the within-subjects means, the between-subjects means or the interaction. The post-hoc tests were done in order to explore further the patterns of within-subjects parameter changes with the duration of treatment in both groups. The unwanted events reported during treatment with lisinopril and during placebo treatment were compared for statistical significance with the Koch's adaptation of Wilcoxon-Mann-Whitney- rank-sum test.

Oligospermia

Oligospermia Male infertility Lisinopril

null

2

arm 1: Started with Placebo until the crossover. arm 2: Started with Lisinopril until the crossover

[ 2, 0 ]

1

[ 0 ]

intervention 1: The two groups of patients, A and B, were randomly allocated treatments in a double-blind fashion. Group A was started on the coded drug "DY1" while group B was started on the coded drug "DZ2". Both "DY1" and "DZ2" were very identical in appearance. At week 96 the drugs were swopped between the groups such that group A changed to drug "DZ2" while group B changed to drug "DY1". There was no intervening washout period. The codes were concealed until after the data analysis.

intervention 1: Lisinopril

1

Enugu | Enugu State | Nigeria | 7.49883 | 6.44132

0

NCT01409837

[ 4 ]

95

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

null

This study is designed to evaluate the repeat-dose safety and effectiveness of a bronchodilator inhaler relative to placebo (inactive drug inhaler) in children aged 4-11 years with asthma. The dosing period lasts three weeks and starts following a three-week run-in period.

null

Asthma

Asthma Pediatric asthma

null

2

arm 1: ProAir(TM) HFA, Breath Actuated Inhalation Aerosol arm 2: Placebo

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: Albuterol 90mcg intervention 2: Placebo

intervention 1: Albuterol intervention 2: Placebo

14

0

NCT00308685

[ 4 ]

127

RANDOMIZED

CROSSOVER

0TREATMENT

null

false

0ALL

false

The objectives of this study are to evaluate and compare patient preference for FF (Fluticasone Furoate) and FP (Fluticasone Propionate Aqueous)nasal sprays in the treatment of allergic rhinitis following single-dose administration.

null

Rhinitis, Allergic, Perennial

taste questionnaire preference attributes odor after taste scent

null

2

arm 1: 200 micrograms (mcg); an aqueous suspension of microfine FP arm 2: 110 mcg; an aqueous suspension containing 0.05% w/w of micronized FF

[ 1, 1 ]

2

[ 0, 0 ]

intervention 1: 200 micrograms (mcg); an aqueous suspension of microfine FP intervention 2: 110 mcg; an aqueous suspension containing 0.05% w/w of micronized FF

intervention 1: fluticasone propionate (FP) intervention 2: fluticasone furoate (FF)

14

0

NCT00398476

[ 5 ]

251

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

null

Community based study assessing safety and efficacy of levetiracetam in partial onset seizures. The optimal dose in daily clinical practice will be used.

null

Epilepsy, Partial

Epilepsy Partial Onset Seizures Keppra Levetiracetam

null

1

arm 1: Subjects received open-label Levetiracetam.

[ 0 ]

1

[ 0 ]

intervention 1: * Pharmaceutical form: oral tablets * Concentration: 500 mg * Route of administration: Oral use

intervention 1: Levetiracetam

29

Hong Kong | N/A | Hong Kong | 114.17469 | 22.27832 Hong Kong | N/A | Hong Kong | 114.17469 | 22.27832 Kwun Tong | N/A | Hong Kong | 114.22176 | 22.31184 Kuala Lumpur | N/A | Malaysia | 101.68653 | 3.1412 Kuala Lumpur | N/A | Malaysia | 101.68653 | 3.1412 Kuala Lumpur | N/A | Malaysia | 101.68653 | 3.1412 Manila | N/A | Philippines | 120.9822 | 14.6042 Manila | N/A | Philippines | 120.9822 | 14.6042 Quezon | N/A | Philippines | 125.09889 | 7.73028 Singapore | N/A | Singapore | 103.85007 | 1.28967 Singapore | N/A | Singapore | 103.85007 | 1.28967 Singapore | N/A | Singapore | 103.85007 | 1.28967 Changhua | N/A | Taiwan | 120.5512 | 24.0692 Hualien City | N/A | Taiwan | 121.60444 | 23.97694 Kaohsiung City | N/A | Taiwan | 120.31333 | 22.61626 Kaohsiung City | N/A | Taiwan | 120.31333 | 22.61626 Kaohsiung City | N/A | Taiwan | 120.31333 | 22.61626 Taichung | N/A | Taiwan | 120.6839 | 24.1469 Taichung | N/A | Taiwan | 120.6839 | 24.1469 Tainan City | N/A | Taiwan | 120.21333 | 22.99083 Taipei | N/A | Taiwan | 121.52639 | 25.05306 Taipei | N/A | Taiwan | 121.52639 | 25.05306 Taipei | N/A | Taiwan | 121.52639 | 25.05306 Taoyuan District | N/A | Taiwan | 121.3187 | 24.9896 Bangkok | N/A | Thailand | 100.50144 | 13.75398 Bangkok | N/A | Thailand | 100.50144 | 13.75398 Bangkok | N/A | Thailand | 100.50144 | 13.75398 Chiang Mai | N/A | Thailand | 98.98468 | 18.79038 Khon Kaen | N/A | Thailand | 102.833 | 16.44671

0

NCT00160654

[ 3 ]

100

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

The objective of this trial was to establish the dose-response of T2 (the amplitude of the first response of second twitch to train of four (TOF) stimulation, expressed as percentage of control first twitch,T1) in Japanese and Caucasian participants. Part A: Japanese Participants

For most surgical procedures a depth of neuromuscular block of 1-2 twitches after TOF-stimulation is sufficient to avoid unwanted muscular activity. At reappearance of T2, the anesthesiologist might decide to either give (another) maintenance dose of rocuronium or vecuronium when surgery continues, to await spontaneous recovery of neuromuscular block or to reverse the neuromuscular block. Sugammadex (Org 25969) has been shown in previous trials to greatly reduce the time to full recovery when administered at reappearance of T2, both after rocuronium- and vecuronium-induced neuromuscular blockade. The current trial P05956 was conducted in Japan and set up to establish the dose-response relationship of sugammadex given during sevoflurane anesthesia at reappearance of T2 after rocuronium or vecuronium in Japanese participants. In addition to recovery time, also pharmacokinetics and safety of sugammadex were evaluated.

Anesthesia, General

null

10

arm 1: After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered intravenously (IV), followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of T2 a single dose of placebo was administered IV. arm 2: After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV, followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of T2 a single dose of 0.5 mg/kg sugammadex was administered IV. arm 3: After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV, followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of T2 a single dose of 1.0 mg/kg sugammadex was administered IV. arm 4: After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV, followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of T2 a single dose of 2.0 mg/kg sugammadex was administered IV. arm 5: After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV, followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of T2 a single dose of 4.0 mg/kg sugammadex was administered IV. arm 6: After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.04 mg/kg vecuronium IV if necessary. At reappearance of T2 a single dose of placebo was administered IV. arm 7: After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.04 mg/kg vecuronium IV if necessary. At reappearance of T2 a single dose of 0.5 mg/kg sugammadex was administered IV. arm 8: After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.04 mg/kg vecuronium IV if necessary. At reappearance of T2 a single dose of 1.0 mg/kg sugammadex was administered IV. arm 9: After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.04 mg/kg vecuronium IV if necessary. At reappearance of T2 a single dose of 2.0 mg/kg sugammadex was administered IV. arm 10: After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.04 mg/kg vecuronium IV if necessary. At reappearance of T2 a single dose of 4.0 mg/kg sugammadex was administered IV.

[ 2, 0, 0, 0, 0, 2, 0, 0, 0, 0 ]

2

[ 0, 0 ]

intervention 1: After induction of anesthesia an intubation dose of NMBA was administered IV: either 0.9 mg/kg rocuronium or 0.1 mg/kg vecuronium. Maintenance doses of 0.1-0.2 mg/kg rocuronium IV or 0.02-0.04 mg/kg vecuronium IV could be administered if necessary. At reappearance of T2 the randomized single dose of sugammadex (0.5 to 4 mg/kg) IV was administered. intervention 2: After induction of anesthesia an intubation dose of NMBA was administered IV: either 0.9 mg/kg rocuronium or 0.1 mg/kg vecuronium. Maintenance doses of 0.1-0.2 mg/kg rocuronium IV or 0.02-0.04 mg/kg vecuronium IV could be administered if necessary. At reappearance of T2 the randomized single dose of placebo IV was administered

intervention 1: sugammadex intervention 2: Placebo

0

null

0

NCT00591409

[ 1 ]

103

RANDOMIZED

CROSSOVER

7BASIC_SCIENCE

0NONE

true

0ALL

false

Adipose tissue is an active endocrine organ producing several hormones with circulatory and metabolic effects. In 1994, the hormone leptin was discovered. The lack of this hormone explained extreme obesity in rare patients and parenteral substitution restored body weight and metabolic disturbances. It was however soon discovered that most humans had too high levels which were related to development of cardiovascular diseases and diabetes. It was hypothesised that leptin induced vessel dysfunction which could explain this association. In this study, we wanted to examine the association between leptin and vessel function by using the venous occlusion plethysmography method. We used three protocols to evaluate this association. First protocol. In ten healthy males, leptin was infused locally in the forearm and forearm blood flow (FBF) was measured. Second protocol. In ten healthy males, leptin or normal saline was infused locally in the forearm and FBF was measured. Concomitantly, four vasodilatators were infused locally in the forearm in a randomised order and the response (blood flow and fibrinolysis) was measured. Third protocol. In eighty-three patients with known coronary artery disease, three vasodilators were infused locally in the forearm in a random order and response (FBF and fibrinolysis) was measured. The response was related to endogenous leptin levels. The two first protocols were performed in Umeå, Sweden whereas the third was performed in Edinburgh, UK, all in 2006.

Introduction High BMI and particularly fat mass index are associated with increased risk of coronary artery disease and other cardiovascular conditions, but the underlying mechanisms are not well understood. Endothelial dysfunction precedes atherosclerosis and represents an important link between obesity and cardiovascular events. The adipose tissue produces cytokines and hormones (adipokines), which, in excess, may promote cardiovascular disease by proinflammatory, prothrombotic, dyslipidemic and atherosclerotic effects. Leptin is an adipokine with pleiotropic effects and circulating leptin levels are positively associated with the amount of body fat. High plasma leptin levels (hyperleptinemia) associate with the development of atherosclerosis, hypertension and coronary artery disease (CAD). Leptin activates specific leptin receptors expressed, among other tissues, in vascular cells, suggesting that leptin may participate in the development of endothelial dysfunction and atherosclerosis. However, the net effect of leptin on vasomotor function remains unclear, as both vasodilation and vasoconstriction have been reported. Leptin induces release of nitric oxide (NO) in vitro and elicits endothelium-dependent vasodilation in mice by inducing endothelial expression of NO synthase. In addition, studies in humans have shown that leptin infusion exerts vasodilatation. In contrast, others have shown leptin-induced vasoconstriction in vitro and impaired vasodilatation in dogs. Different mechanisms have been proposed causing increased peripheral vascular resistance, such as vascular inflammation, increased sympathetic nervous system (SNS) activity, increased endothelin-1 (ET-1) production, and decreased nitric oxide (NO) bioavailability. Hyperleptinemia has been associated to states of altered fibrinolysis, which is common in diabetes, cardiovascular disease and obesity. However, whether leptin directly influences the endogenous fibrinolytic function remains unclear. The aim of these studies was to evaluate the role of leptin on endothelial function in humans. For this purpose, the vasomotor and the fibrinolytic functions were assessed in healthy men during a state of pharmacologically induced hyperleptinemia. In a parallel study, the endothelial function was assessed in patients with established CAD and related to plasma leptin levels. Material and Methods Subjects Twenty healthy non-smoking male volunteers not taking any regular medication were recruited in Umeå, Sweden. 2). Eighty-three patients with established CAD were recruited from the cardiology outpatient clinic at the Royal Infirmary, Edinburgh, Scotland, and the characteristics of this cohort have been reported previously. These patients had stable angina and had a prior angiographic documentation of ≥50% luminal stenosis of at least one major epicardial coronary vessel. Written informed consent was obtained from each subject and the studies were carried out in accordance with the Declaration of Helsinki. Venous occlusion plethysmography Subjects abstained from alcohol for 24 hours and from food, tobacco and caffeine-containing drinks for at least 4 hours before each study visit. All studies were carried out in a quiet temperature-controlled room maintained at 22-25 degrees Celsius (ºC). A 17-G venous cannula was inserted into the antecubital vein of each arm and the brachial artery of the non-dominant arm was cannulated with a 27-G needle (Cooper's Needle Works Ltd, UK). Bilateral forearm blood flow (FBF) was measured by venous occlusion plethysmography using mercury-in-silastic strain gauges. Blood pressure and heart rate were measured using a semi-automated non-invasive sphygmomanometer. To avoid acute vasomotor effects, all medications were withheld on the morning of each study. Study design Protocol 1 In ten healthy male volunteers, recombinant human leptin (Sigma-Aldrich, Saint-Louis, Missouri, USA) was infused intra-arterially at ascending doses of 80, 800 and 8,000 ng/min (6 minutes each). Heart rate, blood pressure, FBF, leptin, tissue plasminogen activator (tPA) antigen and plasminogen activator inhibitor type 1(PAI-1) antigen concentrations were determined at the end of each dose. Protocol 2 In a double-blind randomized crossover study, ten healthy male volunteers received intra-arterial infusions of either leptin (800 ng/min) or saline on two separate occasions with at least 2 weeks between visits. FBF was measured in the infused and non-infused arms at baseline and at regular intervals during the one-hour leptin/saline infusion. Thereafter four vasodilators were infused concomitantly with intra-arterial leptin/saline infusions; bradykinin (endothelium-dependent vasodilator that releases tPA) at 100, 300 and 1,000 pmol/min (Clinalfa Ltd, Switzerland), acetylcholine (endothelium-dependent vasodilator that does not release tPA) at 5, 10 and 20 µg/min (Clinalfa Ltd, Switzerland), sodium nitroprusside (endothelium-independent vasodilator) at 2, 4 and 8 µg/min (David Bull laboratories, UK) and verapamil (endothelium-independent vasodilator) at 10, 30, 100 µg/min (Abbott UK Ltd) for 6 minutes at each concentration. Vasodilators were infused in a randomized order with a 15-minute saline washout period between each drug. Verapamil was always administered at the end because of its long-lasting vasomotor effects. Venous blood was obtained from the infused and non-infused arms at baseline, before and during infusion of bradykinin, at 60 minutes and at the end of the study protocol. Protocol 3 In patients with CAD (n=83), bilateral FBF was measured before and during intra-arterial infusions of substance P (endothelium-dependent vasodilator that releases tPA) at 2, 4 and 8 pmol/min (Clinalfa Ltd, Switzerland), acetylcholine at 5, 10 and 20 µg/min (as above) and sodium nitroprusside at 2, 4 and 8 µg/min (as above) for 6 minutes at each concentration. Bradykinin was not administered because many subjects were being treated with angiotensin-converting enzyme inhibition and this markedly potentiates its vasodilator and fibrinolytic effects. The vasodilators were administered in a randomized order with a 15-minute saline washout period between each drug. Venous blood samples were obtained before and during intra-arterial infusion of substance P to measure fibrinolytic markers. Venous Sampling and Assays Fasting venous blood samples were drawn into tubes containing acidified buffered citrate or trisodium citrate. Samples were collected immediately onto ice and centrifuged at 2,000 g for 30 min. Platelet-free plasma and serum were stored at -80°C before assay. Brain natriuretic peptide (BNP), cholesterol and glucose concentrations were determined according to clinical routine, and high sensitivity C-reactive protein (hsCRP) with a highly sensitive assay using particle-enhanced immunonephelometry (Behring BN II nephelometer). Plasma leptin concentrations were measured using a double-antibody radioimmunoassay (Millipore, Billerica, Massachusetts, USA). According to the literature, intra- and inter-assay coefficients of variation should be less than 5% at both low (2-4 ng/mL) and high (10-15 ng/mL) leptin concentrations. Plasma tPA and PAI-1 antigen concentrations were determined using enzyme-linked immunosorbent assays (Coaliza®, Chromogenix Ltd) and plasma tPA activity using a photometric method (Coatest tPA, Chromogenix Ltd). According to the manufacture, the coefficients of variation for fibrinolytic assays are 5.9% and 12% for tPA antigen and activity respectively, and 6.2% for PAI-1 antigen. Estimated net release of tPA (antigen and activity) was calculated as previously described after each dose of bradykinin or substance P, as the product of the infused forearm plasma flow and the difference in plasma levels between the infused and non-infused forearms.

Endothelial Dysfunction Obesity Vasodilation Venous Occlusion Plethysmography

null

3

arm 1: This applies to protocol 1 when 10 healthy men got leptin infused locally in the forearm and forearm blood flow (FBF) was measured. The other forearm was used as the control. arm 2: This applies to protocol 2 when 10 healthy men got either a background infusion of leptin or saline locally in the forearm when measuring vasoresponse (FBF) to four vasodilatators. Each participant had two examinations with either leptin or saline and the order was randomised. The other forearm was used as the control. arm 3: This applies to protocol 3 when 83 men and women with known CAD (coronary artery disease) got three vasodilators locally infused in the forearm while measuring vasoresponse (FBF). The other forearm was used as the control.

[ 0, 0, 0 ]

3

[ 0, 0, 0 ]

intervention 1: This applies only to protocol 2 with two arms (leptin or saline) where four vasodilatators (bradykinin, acetylcholine, sodium nitroprusside and verapamil) were infused concomitantly intervention 2: This applies only to protocol 1 when only leptin was given intervention 3: This applies only to protocol 3

intervention 1: Leptin infusion plus vasodilators in healthy men intervention 2: Leptin infusion in healthy men intervention 3: Vasodilators in CAD patients

2

Umeå | N/A | Sweden | 20.25972 | 63.82842 Edinburgh | N/A | United Kingdom | -3.19648 | 55.95206

0

NCT04374500

[ 4 ]

108

NON_RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

This was a multicenter extension of Alkermes' Study ALK21-006 (NCT01218997) designed to assess the long-term safety of repeat monthly doses of naltrexone long-acting injection. All subjects received open-label Medisorb® naltrexone 380 mg (VIVITROL®). Planned treatment duration was up to 3 years. Alkermes terminated the study for business purposes in December 2006. The median duration of treatment among all subjects in this extension study was 43 weeks.

From the date of successful completion of Study ALK21-006 (base study \[NCT01218997\])), all subjects, including those who received oral naltrexone during the base study, were given the option to enroll in this extension study. Study investigators ensured that subjects were opioid-free and did not demonstrate evidence of withdrawal prior to administration of VIVITROL therapy. If the investigator suspected recent clinically significant opioid use, a naloxone challenge test was performed. The naloxone challenge was not performed in a subject presenting clinical signs or symptoms of opioid withdrawal or in a subject whose urine contained opioids.

Alcoholism Opiate Dependence

null

2

arm 1: None arm 2: None

[ 0, 0 ]

2

[ 0, 0 ]

intervention 1: Administered via intramuscular (IM) injection once every 4 weeks. Subjects in this dosing group also received this treatment throughout the base study. intervention 2: Subjects in this dosing group received oral naltrexone 50 mg in the base study, but received only Medisorb naltrexone 380 mg in this extension study, administered via IM injection once every 4 weeks.

intervention 1: Medisorb naltrexone 380 mg intervention 2: Oral naltrexone to Medisorb naltrexone 380 mg

0

null

1

NCT00156936

[ 3 ]

129

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

The purpose of this study is to assess efficacy and safety of Staccato Loxapine in the treatment of acute agitation in schizophrenic patients. The study will be conducted in 120 agitated schizophrenic patients - either newly admitted to a hospital setting or a research unit for acute agitation or already in hospital for chronic underlying conditions. Patients meeting entry criteria will be randomized to one of two doses of Staccato Loxapine or to Staccato Placebo. Following administration of study drug, assessment of agitation state will be conducted at serial time points using standard agitation scales over a 24 hour period.

null

Schizophrenia

Agitation Schizophrenia

null

3

arm 1: Inhaled Staccato Placebo, single dose arm 2: Inhaled Staccato Loxapine 5 mg, single dose arm 3: Inhaled Staccato Loxapine 10 mg, single dose

[ 2, 0, 0 ]

3

[ 0, 0, 0 ]

intervention 1: Inhaled Placebo, single dose intervention 2: Inhaled Staccato Loxapine 5 mg, single dose intervention 3: Inhaled Staccato Loxapine 10 mg, single dose

intervention 1: Inhaled Placebo intervention 2: Inhaled Loxapine 5 mg intervention 3: Inhaled Loxapine 10 mg

1

Upland | California | United States | -117.64839 | 34.09751

1

NCT00369577

[ 2 ]

188

RANDOMIZED

CROSSOVER

0TREATMENT

0NONE

true

0ALL

null

This study will evaluate the definitive bioequivalence of tablets of MK0524A (1000 mg Extended Release (ER) Niacin/ 20 mg laropiprant) from two sources.

null

Dyslipidemia

null

2

arm 1: MK0524A Source 1 (Phase III manufacturing site) arm 2: MK0524A Source 2 (commercial manufacturing site)

[ 1, 1 ]

2

[ 0, 0 ]

intervention 1: Single dose of MK0524A (ER Niacin/laropiprant 1000/20 mg) from Source 1 in one of two treatment periods. intervention 2: Single dose of MK0524A (ER Niacin/laropiprant 1000/20 mg) from Source 2 in one of two treatment periods.

intervention 1: niacin (+) laropiprant (Source 1) intervention 2: Comparator: niacin (+) laropiprant (Source 2)

0

null

1

NCT00944645

[ 4 ]

441

RANDOMIZED

CROSSOVER

0TREATMENT

2DOUBLE

false

0ALL

null

The purpose of this clinical study is to determine the safety and efficacy of an investigational drug in patients with Type 2 diabetes mellitus.

null

Diabetes Mellitus, Type 2

null

2

arm 1: Sitagliptin 10 mg tablet daily for 54 weeks arm 2: Placebo tablet daily for 24 weeks followed by Pioglitazone tablet daily for 30 weeks

[ 0, 2 ]

3

[ 0, 0, 0 ]

intervention 1: sitagliptin 10 mg tablet, once daily for 54 weeks intervention 2: Placebo oral tablet once daily for 24 weeks intervention 3: Pioglitazone 30 mg tablet once daily for 30 weeks

intervention 1: Comparator: Sitagliptin intervention 2: Comparator: Placebo intervention 3: Comparator: Pioglitazone

0

null

0

NCT00106704

[ 2 ]

73

NON_RANDOMIZED

SEQUENTIAL

0TREATMENT

0NONE

false

0ALL

null

The purpose of this study is to evaluate the safety and tolerability as well as find the maximum tolerated dose (MTD) for HKI-272. In addition, this study will examine the effects of the study drug on your tumor, and how your body uses and eliminates HKI-272.

null

Breast Neoplasms

Tumors Neratinib HKI-272 Nerlynx

null

8

arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None arm 7: None arm 8: None

[ 0, 0, 0, 0, 0, 0, 0, 0 ]

1

[ 0 ]

intervention 1: HKI-272

intervention 1: neratinib

5

0

NCT00146172

[ 0 ]

10

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

2MALE

false

The goal of this clinical research study is to evaluate how well ferumoxtran-10, a new Magnetic Resonance Imaging (MRI) contrast agent, can detect cancer in the pelvic lymph nodes or malignant pelvic lymph nodes.

The contrast agent, ferumoxtran-10, is made of ultra small iron oxide particles (USPIO). Once they are injected through vein, they are taken up mostly by liver, spleen, bone marrow, and lymph nodes. It takes about 24 - 36 hours to reach peak uptake in the lymph nodes. The ability of current imaging techniques to detect the lymph nodes disease is known to be less than perfect. Current techniques only use anatomic information (size). Previous studies have shown that this new contrast agent may be able to detect normal and abnormal lymph nodes, using MRI procedure, called MRI lymphangiogram. This new contrast agent is being evaluated to determine whether it can be used to detect normal and abnormal lymph nodes. The study includes 2 parts. The first part will involve you receiving a MRI examination before the contrast is injected. The second part will involve you receiving a MRI examination about 24 hours after the injection. It will take about 20 minutes for each part. If you are already scheduled to have a routine pelvic MRI, the first part of this study will be added at the end of the routine MRI. You will then be asked to return next day to complete the second part of the MRI. If you are not already scheduled to receive a MRI as part of your standard of care, you will come in to the MRI suite at M. D. Anderson and complete both parts over about a 24-hour interval. You will be lying on the MRI examination table during the scanning. At the end of the first part of the study, the contrast will be infused slowly through vein over about 30 minutes in the recovery area. You will then be observed for 30 minutes to 2 hours, depending on your tolerance to the contrast agent. The images taken during the first part will be then be repeated 24-36 hours later. You will receive a follow-up telephone call from a member of the study staff on Day 3. Once the second part of the MRI is performed, your participation in this study will be over. This is an investigational study. This contrast agent is currently being evaluated by FDA and has not been approved yet. A total of 80 patients will take part in this study. All will be enrolled at M. D. Anderson.

Bladder Cancer Genitourinary Cancer Prostate Cancer

Bladder Cancer Genitourinary Cancer Prostate Cancer MR Lymphangiography Ferumoxtran-10 SPIO Ultra-small superparamagnetic agent iron oxide

null

2

arm 1: MR lymphangiography using Ferumoxtran-10 contrast agent. arm 2: MR lymphangiography before injecting Ferumoxtran-10 contrast agent.

[ 0, 1 ]

2

[ 0, 3 ]

intervention 1: Intravenous infusion of 2.6 mg/kg of ferumoxtran-10 intervention 2: First MRI examination before ferumoxtran-10 contrast injected and second MRI examination about 24 hours after injection of contrast agent, each MRI taking 20 minutes.

intervention 1: Ferumoxtran-10 (USPIO) intervention 2: MR lymphangiography

1

Houston | Texas | United States | -95.36327 | 29.76328

0

NCT00147238

[ 5 ]

23

NON_RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

The levels of lopinavir achieved in the blood following oral ingestion of standard doses of Kaletra (lopinavir/ritonavir) in HIV-infected men was compared with those achieved in HIV-infected women receiving the same dose of the drug.

The association between patient sex and the tolerability of antiretroviral drugs (ARVs) is increasingly being recognized. Several lines of evidence suggest that women are more likely than men to develop side effects to ARVs. On the other hand, it has been generally accepted that the efficacies of the ARVs are similar in both sexes. However, recent studies suggest that this may not always be the case. In addition to these observed sex-related differences in the effects of ARVs, there is growing evidence that the pharmacokinetic profile of some of these drugs may be different among male and female HIV infected patients. The fact that female sex is a risk factor for enhanced antiretroviral effects (including toxicities) has an important implication, particularly from a global health perspective as women now represent the fastest growing segment of the HIV/AIDS epidemic. Therefore, an understanding of the magnitude, clinical significance, and the mechanisms underlying this phenomenon deserves further study. Knowledge acquired from such studies will likely contribute to improved survival among female HIV-infected patients, through optimization of antiretroviral therapeutic regimens in manners that minimize serious adverse effects and improve adherence. Similarly, the influence of race on the pharmacological effects of ARVs deserves further investigation. Although, there is no reason to believe based on available evidence that racial differences exist in the pharmacological effects of ARVs, the need however exists to explore the influence of race on ARVs pharmacokinetics and treatment outcomes. This is so because data on race related differences on ARV effects is limited, and in addition, people of ethnic minority have been disproportionately under represented in clinical trials involving these drugs in spite of the fact that they bear a larger burden of the HIV epidemic. Our study will examine the influence of race and sex on the 24-hr pharmacokinetics of lopinavir/ritonavir (an antiretroviral agent commonly used in naïve patients) following a switch from LPV/r 400/100 mg twice daily to 800/200 mg once daily dosing. Tolerability (measured by toxicity grade of diarrhea) and change in quality of life following switch from twice daily to once daily dosing will also be assessed using appropriate validated measurement tools.

HIV Infections

Sex differences Pharmacokinetic Lopinavir/ritonavir Treatment Experienced HIV-infection

null

2

arm 1: LPV/r 800/200 mg once daily arm 2: LPV/r 800/200 mg once daily

[ 1, 0 ]

1

[ 0 ]

intervention 1: LPV/r 800/200 mg once daily

intervention 1: LPV/r

1

Atlanta | Georgia | United States | -84.38798 | 33.749

0

NCT00148759

[ 4 ]

108

NON_RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

This was a Phase 3, multi-center extension of Alkermes' Study ALK21-003EXT (NCT01218971) to further assess the long-term safety of repeat monthly doses of Medisorb® naltrexone (VIVITROL®).

Enrolled subjects continued to receive the same dose strength of Medisorb naltrexone (ie, 190 mg or 380 mg) they had received in Study ALK21-003-EXT (NCT01218971). Assigned dose strength (high or low) was not revealed to the subject, the study investigators, or any blinded member of the clinical study team for the duration of the study period. Placebo was not administered.

Alcoholism

Alcohol dependence

null

2

arm 1: None arm 2: None

[ 0, 0 ]

2

[ 0, 0 ]

intervention 1: Administered via intramuscular (IM) injection once every 4 weeks for up to 3.5 years. intervention 2: Administered via IM injection once every 4 weeks for up to 3.5 years.

intervention 1: Medisorb naltrexone 380 mg intervention 2: Medisorb naltrexone 190 mg

0

null

0

NCT00156923

[ 5 ]

312

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

true

The purpose of this study is to compare three treatment regimens in patients who have received a liver transplant for end-stage liver disease caused by Chronic Hepatitis C infection.

End-stage liver disease due to Hepatitis C virus (HCV) infection is the most common reason for liver transplantation in the United States. Patients who have HCV will always carry the virus in their body. If patients respond to treatment, the virus is no longer active. This means that although the virus is still present, it is not currently causing damage to their liver. Because recurrence of HCV is virtually universal in HCV positive transplant recipients and is associated with long term, possibly lethal complications, the search for the most appropriate therapies must also include methods to prevent or minimize recurrence or disease progression, if the goal of improving long term outcomes for these patients is to be achieved. Corticosteroids and high doses of immunosuppressive agents have been associated with increased rates of HCV recurrence. Finding a regimen that provides adequate immunosuppression to prevent early and late rejection episodes, and minimizes steroid usage as well as high doses of other immunosuppressive agents is highly desirable. This study is being conducted to determine the most effective immunosuppressive regimen that will prevent allograft rejection, minimize adverse events and at the same time, prevent or reduce the incidence of HCV recurrence following liver transplant.

End Stage Liver Disease Hepatitis C

Hepatitis C Virus Immunosuppressive Agents

null

3

arm 1: immunosuppressant treatment regimens the intervention is antirejection treatment with the above labeled drugs tacrolimus and cyclosporine arm 2: immunosuppressant treatment regimensthe intervention is antirejection treatment with the above labeled drugs MMF tacrolimus and cyclosporine arm 3: immunosuppressant treatment regimens

[ 1, 1, 1 ]

4

[ 0, 0, 0, 0 ]

intervention 1: anti-rejection drug intervention 2: anti rejection drug intervention 3: anti rejection drug intervention 4: anti rejection drug

intervention 1: Daclizumub intervention 2: Tacrolimus intervention 3: Cyclosporine intervention 4: MMF

1

Dallas | Texas | United States | -96.80667 | 32.78306

0

NCT00163657

[ 5 ]

75

RANDOMIZED

PARALLEL

0TREATMENT

1SINGLE

false

0ALL

true

This is the first comparison of efficacy of Betaseron and Copaxone for treatment of relapsing forms of MS.

We propose to perform a head to head comparison of Interferon beta and Copaxone for treatment of patients with CIS and RR forms of MS using acute changes on MRI as primary outcome. The study will be performed at the two clinical practice sites of the Multiple Sclerosis Center at University of Medicine and Dentistry New Jersey-New Jersey Medical School, One of the two FDA approved preparations of higher dose interferon beta (Betaseron) will be compared at standard dose every other day (QOD) 250 ug subcutaneously(SQ) with Copaxone at 20mg SQ daily (QD) in 70 to 80 patients. Although the current approved plan is to perform monthly MRIs for 1 year followed by another MRI at 2 years, the protocol has been changed to continue performing monthly MRIs during the second year of the study for all patients who complete their first year and up to January 31, 2006 when the study will end. The study uses brain imaging with 3 Tesla MRI with triple dose Gadolinium for primary and secondary outcomes and several clinical and cognitive measures for secondary outcomes. The sample size was estimated to detect a 40-50% difference in the number of active MS lesions by MRI between the two arms at 1 year follow up, consistent with the primary outcome measure. The primary outcome measure is the number of "combined-active" lesions by monthly MRI at the conclusion of the study, which includes contrast enhancing lesions and non-enhancing lesions on long Time repetition (TR) scans that have appeared since the most recent examination. Several secondary MRI outcome measures are studied in addition to the number of enhancing lesions and the number of new lesions on long TR images. We will examine the number of patients who remain "combined-active disease-free" for the duration of the study and the number of "combined-active disease-free" scans. Apart from these traditional methods of analysis by a reader who will be blinded to patient clinical status and therapy, objective volumetric analysis will be carried out. Making use of both automated and manual techniques, we will determine the overall burden of disease (the volume of lesions on long TR scans), the burden of active disease (the volume of brain enhancement) and the burden of chronic disease (the volume of lesions that are markedly hypointense on T1). Another MRI outcome measures will be detection of diffusion anisotropy differences, MR spectroscopy, and magnetization transfer ratio as summarized in Appendix 5. These new techniques have shown promise for detecting disease that cannot be detected with conventional MRI (13, 37). In addition to MRI, several clinical and cognitive outcome measures will be used for secondary analysis. These include the number and severity of relapses measured by different methods, and change in disability measured by the Expanded Disability Status Scale (EDSS), the Neurological Rating Scale, and the Multiple Sclerosis Functional Composite (MSFC). The cognitive measures will be the subject's neurocognitive function measured by standard neurocognitive examination obtained by a licensed neuropsychologist and the Cognitive Stability Index (CSI), a novel Internet-based test of cognitive function in addition to the Paced Auditory Serial Addition Test (PASAT),which is a component of the MSFC.

Multiple Sclerosis

Multiple Sclerosis Brain Betaseron Copaxone MRI

null

2

arm 1: Betaseron 250 micrograms SQ every other day and Triple-Dose Gadolinium at each MRI arm 2: Copaxone 20 mg daily SQ and Triple-Dose Gadolinium at each MRI

[ 1, 1 ]

2

[ 0, 0 ]

intervention 1: Betaseron 250 micrograms injected SQ every other day intervention 2: Copaxone 20 mg injected SQ every day (glatiramer acetate)

intervention 1: Betaseron intervention 2: Copaxone

1

Newark | New Jersey | United States | -74.17237 | 40.73566

0

NCT00176592

[ 4 ]

2,038

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

false

The purpose of this study is to assess the efficacy and safety of 8 weeks of once-daily (QD) treatment with dexlansoprazole modified release (MR) 60 mg or 90 mg or lansoprazole 30 mg in healing subjects with endoscopically proven erosive esophagitis.

This is a Phase 3, randomized, double-blind, multi-center, active-controlled, 3-arm study with an 8-week treatment period. This study will compare the efficacy of dexlansoprazole MR (60 mg QD and 90 mg QD) with that of lansoprazole (30 mg) when administered orally as a single daily dose in the morning, before breakfast. The study is designed to evaluate healing of erosive esophagitis and the effect of the therapy on relieving gastroesophageal reflux disease-related symptoms. The study consists of two periods, a screening period (maximum 21 days) and a treatment period, which will last 8 weeks.

Esophagitis, Reflux Esophagitis, Peptic

Erosive Esophagitis

null

3

arm 1: None arm 2: None arm 3: None

[ 0, 0, 1 ]

3

[ 0, 0, 0 ]

intervention 1: Dexlansoprazole MR 60 mg, capsules, orally, once daily (QD) for up to 8 weeks. intervention 2: Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks. intervention 3: Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.

intervention 1: Dexlansoprazole MR intervention 2: Dexlansoprazole MR intervention 3: Lansoprazole

140

0

NCT00251693

[ 4 ]

2,054

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

false

This is a study to assess the efficacy and safety of 8 weeks of treatment with Dexlansoprazole modified release (MR)(60 mg daily and 90 mg daily) compared to Lansoprazole (30 mg daily) in healing subjects with endoscopically proven erosive esophagitis.

This is a Phase 3, randomized, double-blind, multi-center, active-controlled, 3-arm study with an 8 week treatment period. This study will compare the efficacy of Dexlansoprazole MR (60 mg and 90 mg) with that of Lansoprazole (30 mg) when administered orally as a single daily dose in the morning, before breakfast. The study is designed to evaluate healing of erosive esophagitis and the effect of the therapy on relieving gastroesophageal reflux disease related symptoms. The study consists of two periods, a screening period (maximum 21 days) and a treatment period, which will last up to 8 weeks.

Esophagitis, Reflux Esophagitis, Peptic

Erosive Esophagitis

null

3

arm 1: None arm 2: None arm 3: None

[ 0, 0, 1 ]

3

[ 0, 0, 0 ]

intervention 1: Dexlansoprazole MR 60 mg, capsules, orally, once daily (QD) for up to 8 weeks. intervention 2: Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks. intervention 3: Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.

intervention 1: Dexlansoprazole MR intervention 2: Dexlansoprazole MR intervention 3: Lansoprazole

144

0

NCT00251719

[ 3 ]

20

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

true

While new treatments for metastatic and recurrent colorectal cancer have become available over the past several years, this disease remains incurable with a limited life expectancy from the time of diagnosis. New strategies for treatment of disseminated colorectal cancer are needed. Under this proposal, patients with advanced colorectal cancer will receive Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) to stimulate endogenous dendritic cells and enhance anti-tumor immune mechanisms. This will be combined with standard chemotherapy and patients will be followed for response and overall survival. Detailed correlative laboratory analysis will also be performed to define the extent of dendritic cell and cellular immune system stimulation.

null

Colon Cancer Rectal Cancer

Metastatic colon cancer Metastatic rectal cancer

null

1

arm 1: Granulocyte-macrophage colony-stimulating factor (GM-CSF) 250ug/m\^2 SQ QD with a cap of 500mcg SQ QD

[ 0 ]

1

[ 0 ]

intervention 1: 250ug/m\^2 SQ QD with a cap of 500mcg SQ QD

intervention 1: GM-CSF

1

Orange | California | United States | -117.85311 | 33.78779

0

NCT00257322

[ 3 ]

77

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

The goal of this trial was to explore the utility of evaluating emphysema progression through CT scans measuring lung density during a 2 year period of weekly infusions of either placebo or human alpha-1-antitrypsin (AAT; Prolastin®). Exacerbation data recorded in patient diaries were also collected. All efficacy data were analyzed for potential use in evaluating Prolastin efficacy in this and other clinical trials.

This is a one to one randomized, placebo-controlled, clinical, exploratory study with the aim of collecting information on possible clinical endpoints i.e., the progression of emphysema by lung density measurements with CT scan and frequency of exacerbations that could be used for a subsequent placebo controlled clinical trial. Progression of disease will be investigated in 80 patients with alpha-1-antitrypsin deficiency, who will be treated with human alpha-1-antitrypsin (AAT; Prolastin®) or placebo weekly for two years to analyze the effect of treatment on lung density and exacerbations. Targeted augmentation therapy with weekly infusions of Prolastin® will be a dose of 60 mg/kg body weight (range of 51.72 to 71.43 mg per kg body weight). Therefore, this study focuses on several questions: * Is the 15th percentile point calculated by analysis of CT lung histograms a useful endpoint for clinical trials in AAT deficiency? * Is quantitation of exacerbations in AAT-deficient patients a useful endpoint for clinical trials in AAT deficiency? * Are there significant differences between the treatments in favor of Prolastin®?

Alpha 1-Antitrypsin Deficiency

alpha 1 proteinase inhibitor alpha1 proteinase inhibitor congenital emphysema replacement therapy

null

2

arm 1: Prolastin arm 2: None

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: Weekly infusion of 60 mg/kg body weight for 2 years intervention 2: Weekly infusion for 2 years. Albumin (Human) 20% will be diluted with 5% glucose to a final concentration of 2.0%.

intervention 1: Alpha1-Proteinase Inhibitor (Human) intervention 2: Albumin (Human) 20%, United States Pharmacopeia (USP)

3

Hellerup | N/A | Denmark | 12.57093 | 55.73204 Malmo | N/A | Sweden | 13.00073 | 55.60587 Birmingham | England | United Kingdom | -1.89983 | 52.48142

0

NCT00263887

[ 5 ]

886

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

null

A study to compare the clinical efficacy and safety of Levocetirizine vs. Desloratadine in patients suffering from Chronic Idiopathic Urticaria (CIU) measured by the mean pruritus severity score over the first week of treatment

null

Chronic Idiopathic Urticaria

Chronic Idiopathic Urticaria CUTE Levocetirizine Xyzal®

null

2

arm 1: Levocetirizine, once daily, 4 week duration arm 2: Desloratadine, once daily, 4 week duration

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: 5mg oral capsules, once daily, 4 week duration intervention 2: 5mg oral capsules, once daily, 4 week duration

intervention 1: Levocetirizine intervention 2: Desloratadine

80

Bruges | N/A | Belgium | 3.22424 | 51.20892 Brussels | N/A | Belgium | 4.34878 | 50.85045 Liège | N/A | Belgium | 5.56749 | 50.63373 Merksem | N/A | Belgium | 4.44903 | 51.24623 Sint-Niklaas | N/A | Belgium | 4.1437 | 51.16509 Woluwe-St-Lamb | N/A | Belgium | N/A | N/A Bernay | N/A | France | 0.59858 | 49.08888 Besançon | N/A | France | 6.01815 | 47.24878 Hyères | N/A | France | 6.12857 | 43.12038 Les Milles | N/A | France | 5.38576 | 43.50243 Marseille | N/A | France | 5.38107 | 43.29695 Montpellier | N/A | France | 3.87635 | 43.61093 Nancy | N/A | France | 6.18496 | 48.68439 Nantes | N/A | France | -1.55336 | 47.21725 Nice | N/A | France | 7.26608 | 43.70313 Nîmes | N/A | France | 4.35788 | 43.83665 Paris | N/A | France | 2.3488 | 48.85341 Poitiers | N/A | France | 0.34348 | 46.58261 Quimper | N/A | France | -4.09795 | 47.99597 Saint-Mandé | N/A | France | 2.41579 | 48.83864 Troyes | N/A | France | 4.08524 | 48.30073 Valence | N/A | France | 4.90956 | 44.9256 Villejuif | N/A | France | 2.35992 | 48.7939 Augsburg | N/A | Germany | 10.89851 | 48.37154 Berlin | N/A | Germany | 13.41053 | 52.52437 Cologne | N/A | Germany | 6.95 | 50.93333 Dresden | N/A | Germany | 13.73832 | 51.05089 Düsseldorf | N/A | Germany | 6.77616 | 51.22172 Erlangen | N/A | Germany | 11.00783 | 49.59099 Göttingen | N/A | Germany | 9.93228 | 51.53443 Hamburg | N/A | Germany | 9.99302 | 53.55073 Hanover | N/A | Germany | 9.73322 | 52.37052 Leipzig | N/A | Germany | 12.37129 | 51.33962 Mahlow | N/A | Germany | 13.40954 | 52.36017 Mainz | N/A | Germany | 8.2791 | 49.98419 München | N/A | Germany | 13.31243 | 51.60698 Viersen | N/A | Germany | 6.39441 | 51.25435 Caserta | N/A | Italy | 14.33231 | 41.07262 Catania | N/A | Italy | 15.07041 | 37.49223 Cesena | N/A | Italy | 12.24315 | 44.1391 Genova | N/A | Italy | 11.87211 | 45.21604 Modena | N/A | Italy | 10.92539 | 44.64783 Palermo | N/A | Italy | 13.3636 | 38.1166 Pavia | N/A | Italy | 9.15917 | 45.19205 Roma | N/A | Italy | 11.10642 | 44.99364 Siena | N/A | Italy | 11.33064 | 43.31822 Udine | N/A | Italy | 13.23715 | 46.0693 Verona | N/A | Italy | 10.9938 | 45.43854 Johor Bharu | N/A | Malaysia | N/A | N/A Kelantan | N/A | Malaysia | N/A | N/A Kuala Lumpur | N/A | Malaysia | 101.68653 | 3.1412 Negeri Sembilan | N/A | Malaysia | N/A | N/A Perak | N/A | Malaysia | 102.5862 | 3.8682 Pulau Pinang | N/A | Malaysia | 102.56667 | 3.55 Sarawak | N/A | Malaysia | N/A | N/A Brasov | N/A | Romania | 25.60613 | 45.64861 Bucharest | N/A | Romania | 26.10626 | 44.43225 Dolj | N/A | Romania | N/A | N/A Sibiu | N/A | Romania | 24.15 | 45.8 Cape Town | N/A | South Africa | 18.42322 | -33.92584 Durban | N/A | South Africa | 31.0292 | -29.8579 Lenasia | N/A | South Africa | 27.83564 | -26.32052 A Coruña | N/A | Spain | -8.396 | 43.37135 Albacete | N/A | Spain | -1.85643 | 38.99424 Barcelona | N/A | Spain | 2.15899 | 41.38879 Granada | N/A | Spain | -3.60667 | 37.18817 Madrid | N/A | Spain | -3.70256 | 40.4165 Málaga | N/A | Spain | -4.42034 | 36.72016 Murcia (El Palmar) | N/A | Spain | -1.13004 | 37.98704 Oviedo | N/A | Spain | -5.84476 | 43.36029 Santiago de Compostela | N/A | Spain | -8.54569 | 42.88052 Seville | N/A | Spain | -5.97317 | 37.38283 Valencia | N/A | Spain | -0.37966 | 39.47391 Amersham | N/A | United Kingdom | -0.61667 | 51.66667 Cardiff | N/A | United Kingdom | -3.18 | 51.48 Irvine | N/A | United Kingdom | -4.65508 | 55.6194 Leicester | N/A | United Kingdom | -1.13169 | 52.6386 London | N/A | United Kingdom | -0.12574 | 51.50853 Nuneaton | N/A | United Kingdom | -1.46523 | 52.52323 Salford | N/A | United Kingdom | -2.29042 | 53.48771

0

NCT00264303

[ 3 ]

249

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

The objective of this study is to evaluate the safety and efficacy of two investigational drugs (MK-0736 and MK-0916) in lowering blood pressure and body weight in patients with hypertension (high blood pressure). This is an early phase trial and some specific protocol information is proprietary and not publicly available at this time. (Full information is available to trial participants).

Participants enrolled in the study will be separated into 2 strata based on baseline body mass index (BMI) assessments prior to being randomly assigned to study treatment. Study will include a 24-week treatment period comprised of 2 phases, A and B, each of which will 12 weeks in duration.

Hypertension

null

6

arm 1: Participants administered MK-0736 2mg tablet once daily for 12 weeks (Phase A) then administered placebo once daily for 12 weeks (Phase B) arm 2: Participants administered MK-0736 7mg tablet once daily for 12 weeks (Phase A) then administered placebo once daily for 12 weeks (Phase B) arm 3: Participants administered MK-0916 6mg tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks) arm 4: Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks) arm 5: Participants administered MK-0916 6mg tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks) arm 6: Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)

[ 0, 0, 0, 2, 0, 2 ]

3

[ 0, 0, 0 ]

intervention 1: None intervention 2: None intervention 3: None

intervention 1: MK0736 intervention 2: MK0916 intervention 3: Placebo

0

null

0

NCT00274716

[ 3 ]

96

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

A significant proportion of advanced gastric cancer (AGC) occurs in individuals 65 years of age and older. In addition, patient delay in seeking care for symptoms results in diagnosis at a more advanced stage than that seen in younger individuals. However, clinical trials on gastric cancer rarely have been available to the elderly. Recently oral 5-FU pro-drugs, which have been reported to have clinically significant response rates and survival with mild or negligible toxicities, have been widely used for the patients with AGC. However, few studies have been conducted in elderly patients.

null

Gastric Cancer

Stomach cancer Palliative chemotherapy Capecitabine S-1

null

2

arm 1: None arm 2: None

[ 1, 1 ]

2

[ 0, 0 ]

intervention 1: None intervention 2: None

intervention 1: S-1 intervention 2: Capecitabine

9

Goyang-si | Gyeonggi-do | South Korea | 126.835 | 37.65639 Pyeongchon | Gyeonggido | South Korea | 127.26395 | 37.92595 Daegu | N/A | South Korea | 128.59111 | 35.87028 Daegu | N/A | South Korea | 128.59111 | 35.87028 Incheon | N/A | South Korea | 126.70515 | 37.45646 Seoul | N/A | South Korea | 126.9784 | 37.566 Seoul | N/A | South Korea | 126.9784 | 37.566 Seoul | N/A | South Korea | 126.9784 | 37.566 Ulsan | N/A | South Korea | 129.31667 | 35.53722

0

NCT00278863

[ 4 ]

22

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

The purpose of this study is for compassionate use of nitazoxanide in the treatment of diarrheal disease due to Clostridium difficile infection when the patient has failed previous treatment with metronidazole or vancomycin.

Clostridium difficile is the leading cause of nosocomial diarrheal disease associated with antibiotic therapy. This is a debilitating condition with substantial morbidity and a mortality that may be around 2-3%. There has been an enormous increase in this disease at the VA Medical Center during the past two years, just as has occurred at other hospitals throughout the United States. Currently recommended therapy for this condition is metronidazole, given orally. About 15-20% of patients fail to respond to initial therapy with metronidazole, and another 20% relapse after treatment. Relapses may be treated with another course of metronidazole; about one-half will respond to this therapy. The failures are treated with oral vancomycin, but this drug also has a failure rate of 10-20%. There is, at present, no other accepted therapy (although some articles in the literature favor vancomycin with ingested bacteria from benign species). Furthermore, there is a strong risk to the emergence of resistant bacteria when hospitalized patients are treated with oral vancomycin. Nitazoxanide is an FDA approved drug that is marketed in the U.S. and has been widely used throughout the world to treat parasitic diseases of the gastrointestinal tract; several million children have been treated with this drug during the past decade. Nitazoxanide has been approved as an antiprotozoal agent for oral administration in pediatric patients, ages 1 through 11, with diarrhea. The drug acts by interfering with anaerobic metabolic pathways, and it has been shown to have excellent in vitro activity against C. difficile. We hypothesized that this drug was both safe and effective as an alternative in patients who have diarrheal disease caused by C. difficile. The IRB approved a double-blind protocol to compare metronidazole with nitazoxanide, and we have treated a total of 16 patients so far under this protocol. In our IRB-approved double blind study (by design, two thirds of the subjects have been randomized to the nitazoxanide), our patients have appeared to have a good response rate -- so good, in fact, that we think that nitazoxanide may be a better drug to treat this infection than either metronidazole or vancomycin.

Clostridium Enterocolitis Pseudomembranous Colitis

Clostridium difficile Associated Diarrhea

null

1

arm 1: 500 mg nitazoxanide bid given to patient

[ 5 ]

1

[ 0 ]

intervention 1: 500 mg bid

intervention 1: Nitazoxanide

2

0

NCT00304356

[ 4 ]

291

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

1FEMALE

false

The purpose of this study is to evaluate the efficacy, safety, and tolerability of VIT45 compared to the current standard of care in postpartum patients.

This is an open label Phase III randomized active control study of postpartum patients with anemia. Patients will be randomized to either active control or the investigational agent and followed for up to 6 weeks.

Postpartum Anemia

anemia postpartum

null

2

arm 1: Up to a maximum cumulative dose of 2,500 mg administered IV based on iron-deficit calculations; the calculated dose was given in divided doses of up to 1,000 mg weekly. arm 2: 325 mg of ferrous sulfate 3 times daily (TID) x 6 weeks.

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: Up to a maximum cumulative dose of 2,500 mg administered IV based on iron-deficit calculations; the calculated dose was given in divided doses of up to 1,000 mg weekly. intervention 2: 325 mg of ferrous sulfate 3 times daily (TID) x 6 weeks.

intervention 1: Ferric Carboxymaltose (FCM) intervention 2: Ferrous Sulfate tablets

1

Norristown | Pennsylvania | United States | -75.3399 | 40.1215

0

NCT00354484

[ 4 ]

200

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

null

A multicenter study to evaluate the analgesic efficacy of XP21L in subjects with pain following bunionectomy surgery.

null

Pain, Postoperative

Bunionectomy Bunion surgery Post-operative pain

null

2

arm 1: None arm 2: None

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: 25 mg capsule, every 6 hours intervention 2: Oral placebo capsule, every 6 hours

intervention 1: diclofenac potassium (XP21L) intervention 2: Placebo

4

0

NCT00375934

[ 4 ]

3,095

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

true

Cycloset, a new quick-release oral formulation of bromocriptine mesylate, effectively reduces blood sugar by the proposed mechanism of reversing many of the metabolic alterations associated with insulin resistance and obesity by resetting central (hypothalamic) circadian organization of monoamine neuronal activities. The primary analysis of this study will test the hypothesis that the rate of all-cause severe adverse events for those receiving usual drug therapy for diabetes management plus Cycloset is not greater than that for usual drug therapy plus placebo by more than an acceptable margin. While the primary purpose of this study is to establish the safety profile of Cycloset in type 2 diabetes, any potential positive cardiovascular benefits will be evaluated as well.

Bromocriptine mesylate, an ergot derivative, is a sympatholytic dopamine D2 receptor agonist that can exert inhibitory effects on serotonin turnover in the central nervous system. It has been proposed that bromocriptine can reverse many of the metabolic alterations associated with insulin resistance and obesity by resetting central (hypothalamic) circadian organization of monoamine neuronal activities. While Cycloset has demonstrated efficacy by reducing HbA1c, fasting and post-prandial glucose and fasting and post-prandial triglycerides, the relatively small numbers of individuals treated for type 2 diabetes during the controlled Phase III clinical trials of Cycloset did not allow for a full evaluation of the safety profile. Since persons with diabetes are already at higher risk for cardiovascular disease, it is important to examine more fully the spectrum of potential adverse or positive effects from Cycloset in a large sample of persons with diabetes. Accordingly, the present study is designed to investigate the clinical safety of treatment with Cycloset in a broad population of persons with type 2 diabetes. To determine in subjects with type 2 diabetes mellitus receiving Usual Diabetes Therapy (UDT) consisting of either diet, oral hypoglycemic agents (OHA) (no more than 2), or insulin (with or without no more than 1 OHA) plus either Placebo or Cycloset: 1. Whether add-on therapy with Cycloset results in all-cause rate of serious adverse events, which are not higher than add-on therapy with Placebo. 2. Whether add-on therapy with Cycloset results in disease-specific rate of serious cardiovascular adverse events, which are not higher than add-on therapy with Placebo. While the primary purpose of this study is to establish the safety profile of Cycloset in type 2 diabetes, any potential positive cardiovascular benefits will be evaluated as well. Other clinical measures: 3. The impact (either positive or negative) of Cycloset on HbA1c, fasting plasma glucose, weight, triglycerides lipids, blood pressure and patient tolerability after 12 months of therapy. Furthermore, Hba1c changes from baseline to 24 weeks between Cycloset and Placebo among subjects with a baseline Hba1c of \>= 7.5% among the following subgroups: A. Treated at baseline with any Oral hypoglycemic agent (OHA) including injectable insulin secretagogues B. Metformin plus or minus one OHA or injectable insulin secretagogue C. Sulphonylurea plus or minus one OHA or injectable insulin secretagogue D. Treated at baseline with Metformin and one sulphonylurea

Type 2 Diabetes Mellitus

diabetes diabetes mellitus

null

2

arm 1: Usual diabetes therapy plus placebo arm 2: None

[ 0, 0 ]

2

[ 0, 0 ]

intervention 1: Usual diabetes therapy plus Cycloset intervention 2: Placebo tablet taken orally once in the morning, beginning with one tablet daily, titrated up by 1 tablet each week to a maximum of 6 tablets daily

intervention 1: Cycloset intervention 2: Usual Diabetes Therapy plus placebo

0

null

0

NCT00377676

[ 3 ]

60

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

null

The main objectives of this study are to evaluate the efficacy and safety of combination therapy BMS-201038 (AEGR-733) plus ezetimibe vs. each agent given alone on LDL cholesterol and other lipoproteins over 12 weeks of therapy.

Subjects will participate in this study for approximately 14-17 weeks. This study has 2 periods: 1) a 1-2-week screening period with 2 visits where baseline cholesterol and other characteristics will be evaluated to determine study eligibility. This period also includes a 4-week washout for patients on prior lipid-lowering therapies; and 2) a 12-week treatment period with interim visits at weeks 4 and 8. 85 subjects were randomized into one of 3 treatment arms with equal probability. In treatment arm 1, subjects will receive BMS-201038 (AEGR-733) 5 mg plus ezetimibe placebo. In treatment arm 2, subjects will receive BMS-201038 (AEGR-733) placebo plus 10 mg of ezetimibe. In treatment arm 3, subjects will receive BMS-201038 (AEGR-733) 5 mg plus ezetimibe 10 mg. After 4 weeks of treatment, subjects in arms 1 and 3 will be force-titrated to BMS-201038 (AEGR-733) 7.5 mg. After another 4 weeks of treatment, subjects in arms 1 and 3 will then be force-titrated to BMS-201038 (AEGR-733) 10 mg for 4 more additional weeks of treatment. Subjects in arm 2 will continue to receive BMS-201038 (AEGR-733) matching placebo for the entire 12 weeks of treatment. Subjects randomized to ezetimibe 10 mg in arms 2 and 3 and ezetimibe placebo in arm 1 will remain on these doses for the entire 12-week treatment period.

Hypercholesterolemia

Cholesterol

null

0

null

2

[ 0, 0 ]

intervention 1: None intervention 2: None

intervention 1: BMS-201038 (AEGR-733) intervention 2: Ezetimibe

1

Princeton | New Jersey | United States | -74.65905 | 40.34872

0

NCT00405067

[ 3 ]

400

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

Staccato Prochlorperazine is being developed to treat patients suffering from acute migraine headaches. In October 2005, we completed a 75 patient, multi-center, double-blind placebo-controlled Phase 2A clinical trial in patients suffering from moderate to severe acute migraine headaches. This Phase 2B clinical trial of Staccato Prochlorperazine has been initiated to assess the efficacy and safety in outpatients with migraine headache with or without aura.

null

Migraine Headache Aura

Migraine, Staccato Prochlorperazine Migraine headache with or without aura.

null

4

arm 1: Inhaled Staccato Placebo arm 2: Inhaled Staccato Prochlorperazine 5 mg arm 3: Inhaled Staccato Prochlorperazine 7.5 mg arm 4: Inhaled Staccato Prochlorperazine 10 mg

[ 2, 0, 0, 0 ]

4

[ 0, 0, 0, 0 ]

intervention 1: Inhaled Staccato Placebo intervention 2: Inhaled Staccato Prochlorperazine 5 mg intervention 3: Inhaled Staccato Prochlorperazine 7.5 mg intervention 4: Inhaled Staccato Prochlorperazine 10 mg

intervention 1: Inhaled Placebo intervention 2: Inhaled PCZ 5 mg intervention 3: Inhaled PCZ 7.5 mg intervention 4: Inhaled PCZ 10 mg

25

0

NCT00422812

[ 3 ]

181

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

true

1FEMALE

false

To compare the efficacy 50 mg delayed-release risedronate tablet, dosed immediately after breakfast, to a 35 mg immediate-release tablet, administered according to labeling instructions.

To compare the efficacy, based on the bone turnover marker (BTM) serum Type I collagen C-telopeptide (CTx), of a 50 mg delayed-release risedronate tablet, administered immediately after a typical breakfast, to that of a 35 mg immediate-release tablet, administered according to labeling instructions (ie, at least 30 minutes prior to breakfast) in postmenopausal women after 13 weeks of treatment.

Postmenopausal Women

null

4

arm 1: 35 mg immediate release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks arm 2: 35 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks arm 3: 50 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks arm 4: 50 mg delayed release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks

[ 1, 0, 0, 0 ]

4

[ 0, 0, 0, 0 ]

intervention 1: 35mg immediate release risedronate tablet before breakfast, once a week for 13 weeks intervention 2: 35mg delayed release risedronate tablet following breakfast, once a week for 13 weeks intervention 3: 50mg delayed release risedronate tablet following breakfast, once a week for 13 weeks intervention 4: 50mg delayed release risedronate tablet before breakfast, once a week for 13 weeks

intervention 1: risedronate intervention 2: risedronate intervention 3: risedronate intervention 4: risedronate

6

0

NCT00577720

[ 2 ]

13

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

The objective of the study is to determine whether or not inhalation of hypertonic saline will be tolerated by infants with cystic fibrosis and the effect of inhalation on their lung function.

Cystic fibrosis lung disease is characterized by mucous retention which favors secondary bacterial infection and inflammation, which leads to lung damage and ultimately respiratory failure. Classically, therapeutic interventions are aimed to improve mucociliary clearance, to reduce both bacterial load and lower airway inflammation. Hypertonic saline (HS) has been used for the induction of sputum production in all age groups to obtain secretions from the lower respiratory for diagnostic purposes. Hypertonic saline is also used in older children with CF, who do not produce sputum spontaneously, to obtain representative samples for microbiology. There is evidence from studies in patients with cystic fibrosis that HS can improve mucociliary clearance. The improvement was more impressive in areas that were well ventilated, making it likely that HS will work better in patients with relatively preserved pulmonary function. Newer evidence also suggests that the osmotic effect on the airway surface that was expected to be short lived, may actually persist for longer time periods (up to 8 hours). All these data indicate that HS may be a useful agent in the treatment of CF patients. As the effect on mucociliary clearance was found to be better in areas with adequate ventilation, it is logical to assume that treatment with HS may be most efficacious when initiated early in the disease process. So far, no data on the tolerability of inhalation of HS are available for infants with cystic fibrosis. However, evidence from infants with AIDS as well as recent studies in infants with bronchiolitis suggest that hypertonic saline can be safely administered by inhalation in infants. Nevertheless, proof of tolerability in CF infants is a prerequisite for longer term studies of HS in this age group. In older children, tolerability has been tested by measuring pulmonary function both before and after inhalation of HS saline. Similar data are not yet available for infants.

Cystic Fibrosis

Cystic Fibrosis Hypertonic Saline Infants

null

1

arm 1: Administration of a single dose of 7% hypertonic saline

[ 0 ]

1

[ 0 ]

intervention 1: 5 ml of 7% saline will be administered via mask with Pari LC Plus nebuliser and a Pari Ultra Ned compressor.

intervention 1: Hypertonic Saline

1

Toronto | Ontario | Canada | -79.39864 | 43.70643

0

NCT00753987

[ 2 ]

36

RANDOMIZED

CROSSOVER

null

0NONE

true

1FEMALE

false

This study compared the relative bioavailability (rate and extent of absorption) of 0.4 mg/35 mcg Norethindrone and Ethinyl Estradiol Chewable Tablets by Teva Pharmaceuticals, USA with that of 0.4 mg/35 mcg Ovcon® 35 Fe Chewable Tablets manufactured by Warner Chilcott Company, Inc., following a single oral dose (2 \* 0.4 mg/35 mcg chewable tablets) in healthy female adult volunteers administered under fasting conditions.

null

Bioequivalence

Healthy Subjects

null

2

arm 1: Norethindrone/Ethinyl Estradiol 0.4 mg/35 mcg Chewable Tablets (Teva) arm 2: Ovcon® 35 Fe 0.4 mg/35 mcg Chewable Tablets (Warner Chilcott)

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: 0.4 mg/35 mcg Chewable Tablets intervention 2: 0.4 mg/35 mcg Chewable Tablets

intervention 1: Norethindrone/Ethinyl Estradiol intervention 2: Ovcon® 35 Fe

1

Fargo | North Dakota | United States | -96.7898 | 46.87719

0

NCT01340625

[ 5 ]

1,266

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

null

This is a Phase IIIb/IV, open label, multicentre study of efalizumab (anti cluster of differentiation \[CD\] 11a recombinant human monoclonal antibody) in participants with moderate to severe plaque psoriasis who have failed to respond to, have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate, and psoralen and ultraviolet A phototherapy (PUVA).

null

Psoriasis

Candidates for systemic therapy for psoriasis

null

1

arm 1: None

[ 0 ]

1

[ 0 ]

intervention 1: Participants will receive efalizumab 1.0 milligram per kilogram (mg/kg) (with an initial conditioning dose of 0.7 mg/kg) once weekly by subcutaneous injection for 12 weeks (first treatment \[FT\]). Depending on the response at Week 12, participants could receive additional 8 to 12 weekly injections of efalizumab 1.0 mg/kg.

intervention 1: Efalizumab - anti-CD11a recombinant human monoclonal antibody

1

Feltham | N/A | United Kingdom | -0.41388 | 51.4462

1

NCT00249808

[ 4 ]

182

RANDOMIZED

PARALLEL

0TREATMENT

1SINGLE

false

0ALL

true

The purpose of the trial is to demonstrate a faster recovery from neuromuscular block (NMB) induced with rocuronium or vecuronium after reversal by 4.0 mg/kg of Org 25969 compared with reversal by 70 μg/kg of neostigmine in combination with 14 μg/kg glycopyrrolate.

null

Anesthesia, General

null

4

arm 1: Participants received a single bolus dose of 0.60 mg/kg rocuronium prior to intubation. The neuromuscular block was maintained with 0.15 mg/kg rocuronium if needed. At 1-2 post-tetanic counts (PTC) and after the last dose of rocuronium, a single bolus dose of 4.0 mg/kg sugammadex was administered. arm 2: Participants received a single bolus dose of 0.60 mg/kg rocuronium prior to intubation. The neuromuscular block was maintained with 0.15 mg/kg rocuronium if needed. At 1-2 PTC and after the last dose of rocuronium, a single bolus dose of 70.0 μg/kg neostigmine (up to a maximum dose of 5 mg) was administered in combination with 14.0 μg/kg glycopyrrolate. arm 3: Participants received a single bolus dose of 0.1 mg/kg vecuronium prior to intubation. The neuromuscular block was maintained with 0.015 mg/kg vecuronium if needed. At 1-2 PTC and after the last dose of vecuronium, a single bolus dose of 4.0 mg/kg sugammadex was administered. arm 4: Participants received a single bolus dose of 0.1 mg/kg vecuronium prior to intubation. The neuromuscular block was maintained with 0.015 mg/kg vecuronium if needed. At 1-2 PTC and after the last dose of vecuronium, a single bolus dose of 70.0 μg/kg neostigmine (up to a maximum dose of 5 mg) was administered in combination with 14.0 μg/kg glycopyrrolate.

[ 0, 1, 0, 1 ]

5

[ 0, 0, 0, 0, 0 ]

intervention 1: Administered as an intravenous (IV) infusion intervention 2: Administered as an IV infusion intervention 3: Administered as an IV infusion intervention 4: Administered as an IV infusion intervention 5: Administered as an IV infusion

intervention 1: sugammadex intervention 2: neostigmine intervention 3: vecuronium intervention 4: rocuronium intervention 5: glycopyrrolate

0

null

0

NCT00473694

[ 3 ]

58

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

1FEMALE

null

Evaluate the effectiveness of adding lutropin alfa (recombinant human luteinizing hormone \[r-hLH\]) in the middle of the follicular phase compared to no addition, in infertile women at risk of poor response stimulated with follitropin alfa (recombinant Follicle-Stimulating Hormone \[r-FSH\]) under Gonadotropin Releasing Hormone (GnRH) antagonist in vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI), in the number and quality of oocytes, follicular development, fertilization oocyte, embryo quality, and pregnancy rate.

null

Ovarian Stimulation

Lutropin alfa Fertilization in vitro Intracytoplasmic sperm injection Reproductive techniques, assisted

null

2

arm 1: Lutropin alfa (r-hLH) will be administered at a daily dose of 150 International Units (IU) from the presence of at least one follicle greater than (\>) 14 millimeter (mm) to complete ovarian stimulation. Follitropin alfa (r-FSH) will be administered at an initial dose of 225-450 IU per day (according to standard center practice); the dose will then be adjusted to ovarian response as assessed by ovarian ultrasound and/or serum estradiol. Participants will also receive analogous GnRH antagonist and natural progesterone, as per standard center practice. To complete follicular maturation and trigger ovulation, a single dose of 250 milligrams (mg) of recombinant Human Chorionic Gonadotropin (r-hCG) will be administered subcutaneously at 12 hours after the last injection of lutropin alfa and/or follitropin alfa and analogous GnRH antagonist. arm 2: Follitropin alfa (r-FSH) will be administered at an initial dose of 225-450 IU per day (according to standard center practice); the dose will then be adjusted to ovarian response as assessed by ovarian ultrasound and/or serum estradiol. Participants will also receive analogous GnRH antagonist and natural progesterone, as per standard center practice. To complete follicular maturation and trigger ovulation, a single dose of 250 mg of r-hCG will be administered subcutaneously at 12 hours after the last injection of follitropin alfa and analogous GnRH antagonist.

[ 0, 1 ]

5

[ 0, 0, 0, 0, 0 ]

intervention 1: r-FSH will be administered as specified in the arm description. intervention 2: r-hLH will be administered as specified in the arm description. intervention 3: Analogous GnRH antagonist will be administered as specified in the arm description. intervention 4: r-hCG will be administered as specified in the arm description. intervention 5: Progesterone will be administered as specified in the arm description.

intervention 1: r-FSH intervention 2: r-hLH intervention 3: Analogous GnRH antagonist intervention 4: r-hCG intervention 5: Progesterone

1

Valencia | N/A | Spain | -0.37966 | 39.47391

0

NCT01112358

[ 4 ]

741

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

null

The purpose of this clinical study is to determine the safety and efficacy of an investigational drug in patients with type 2 diabetes mellitus.

null

Diabetes Mellitus, Type 2

null

4

arm 1: Phase A and B: Oral tablets of sitagliptin 100 mg Once a Day (q.d ) arm 2: Phase A and B: Oral tablets of sitagliptin 200 mg q.d arm 3: Phase A: Oral tablets of placebo matching sitagliptin 100 mg q.d. Phase B: Oral tablets of sitagliptin 100 mg q.d. arm 4: Phase A: Oral tablets of placebo matching sitagliptin 200 mg q.d. Phase B: Oral tablets of sitagliptin 200 mg q.d.

[ 1, 1, 2, 2 ]

5

[ 0, 0, 0, 0, 0 ]

intervention 1: Phase A: Sitagliptin 100 mg once a day for 24 weeks. Phase B: Sitagliptin 100 mg once a day for 80 weeks. intervention 2: Phase A: Sitagliptin 200 mg once a day for 24 weeks. Phase B: Sitagliptin 200 mg once a day for 80 weeks. intervention 3: Phase A: Placebo matching Sitagliptin 100 mg once a day for 24 weeks. Phase B: Sitagliptin 100 mg once a day for 80 weeks. intervention 4: Phase A: Placebo matching Sitagliptin 200 mg once a day for 24 weeks. Phase B: Sitagliptin 200 mg once a day for 80 weeks. intervention 5: Phase A: Patients not meeting specific glycemic goals will receive open-label metformin as 500 mg, 850 mg, and 1000 mg oral tablets titrated at the discretion of the investigator. Phase B: These patients will not initiate Phase B double-blind medication.

intervention 1: Sitagliptin (MK0431) intervention 2: Sitagliptin intervention 3: Placebo intervention 4: Placebo intervention 5: Metformin - Rescue

0

null

1

NCT00087516

[ 4 ]

325

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

null

The purpose of this study is to test the long-term safety and tolerability of aripiprazole in adolescent patients with schizophrenia, and child and adolescent patients with bipolar I disorder, manic or mixed episode.

null

Schizophrenia Bipolar Disorder

Open Label Aripiprazole Bipolar I Disorder, Manic or Mixed Episode

null

1

arm 1: All subjects had either completed or had withdrawn from the double-blind extension phase of study NCT00110461 (OPDC 31-03-240) and study NCT00102063 (OPDC 31-03-239).

[ 0 ]

1

[ 0 ]

intervention 1: 2 to 30 mg/day orally (2, 5, 10, 15, 20, 25, or 30 mg/day); tablets in strengths of 2, 5, 10, and 15 mg were used to achieve desired doses

intervention 1: Aripiprazole

50

1

NCT00102518

[ 4 ]

296

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

null

The purpose of this trial is to test the safety and efficacy of two doses of aripiprazole in child and adolescent patients with bipolar I disorder, manic or mixed episode with or without psychotic features.

null

Bipolar Disorder

Aripiprazole Bipolar I Disorder, Manic or Mixed Episode with or without Psychotic Features

null

3

arm 1: Aripiprazole 10 mg tablet arm 2: Aripiprazole 30 mg tablet arm 3: Placebo

[ 1, 1, 2 ]

3

[ 0, 0, 0 ]

intervention 1: Treatment Arm 1 (10 mg treatment arm): Aripiprazole 2 mg QD for 2 days, aripiprazole 5 mg QD for 2 days, and aripiprazole 10 mg QD as the target dose starting on Day 5. Subjects remained on the 10 mg dose for the remainder of the treatment period Subjects reached their target dose through a forced titration schedule and proceeded with treatment at their target dose until Week 4. If the subject reached Week 4, he or she continued into the Extension Phase, a 6-month double-blind treatment period, beginning at the same dose taken at the end of the Acute Phase. intervention 2: Treatment Arm 2 (30 mg treatment arm): Aripiprazole 2 mg QD for 2 days, aripiprazole 5 mg QD for 2 days, aripiprazole 10 mg QD for 2 days, aripiprazole 15 mg QD for 2 days, aripiprazole 20 mg QD for 2 days, aripiprazole 25 mg QD for 2 days, and aripiprazole 30 mg QD as the target dose starting on Day 13. Subjects remained on the 30 mg dose for the remainder of the treatment period. Subjects reached their target dose through a forced titration schedule and proceeded with treatment at their target dose until Week 4. If the subject reached Week 4, he or she continued into the Extension Phase, a 6-month double-blind treatment period, beginning at the same dose taken at the end of the Acute Phase. intervention 3: Placebo tablet

intervention 1: Aripiprazole intervention 2: Aripiprazole intervention 3: placebo

53

1

NCT00110461

[ 3 ]

52

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

null

The primary purpose of this protocol is to determine the activity of AG 013736 in patients with metastatic renal cell cancer who have received 1 prior cytokine-based therapy.

null

Kidney Neoplasms

null

0

null

1

[ 0 ]

intervention 1: None

intervention 1: Vascular Endothelial Growth Factor Receptor [VEGFR] and Platelet-Derived Growth Factor Receptor [PDGFR] inhibitor

9

0

NCT00076011

[ 3 ]

9

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

true

This study will evaluate the effectiveness of the experimental drug, Org 24448, for short-term treatment of depression. It will examine the effects of the drug on symptoms, such as low mood and persistent sadness, poor sleep and appetite, poor motivation and lack of enjoyment of things people normally enjoy, negative thinking, and feeling slowed down or having trouble concentrating. It will also assess whether the drug improves cognitive function, especially memory. Patient with major depression who do not have a serious, unstable medical illness and who are 21 to 55 years of age may be eligible for this study. Candidates are screened with a psychiatric and medical history, diagnostic interview, physical examination, electrocardiogram, blood tests and, for women, a pregnancy test. Participants are tapered off anti-depression drugs (and any other medications not allowed on the study) over a 3-week period and then begin a 2-week drug-free period. During these 2 weeks they have an electroencephalogram (EEG) with light stimulation, and those whose EEG indicates a seizure disorder are excluded from the study. Also at the beginning of the drug-free period they begin taking a placebo ("sugar pill") twice a day. After 2 weeks on placebo, some patients begin treatment with Org 24448, while others remain on placebo. They continue the medication for 8 weeks, during which time they have a weekly check of vital signs, blood and urine tests, and rating scales for depression and anxiety. Level of functioning is evaluated twice during the study. After 8 weeks of treatment, patients have a physical exam, electrocardiogram (ECG), EEG, blood tests, and begin to come off the study drug, tapering the medication over a week. In addition to the above procedures, some patients undergo the following tests during the 2-week drug-free period and again toward the end of the 8-week medication phase: * Neuropsychological testing, including measurements of cognitive abilities such as memory, attention, problem-solving, and language skills. * Positron emission tomography (PET): This nuclear medicine test provides information about different brain regions. The patient lies on a table in the PET scanner (similar to a computed tomography (CT) scanner), with a mask placed over his or her face that helps keep the head still. A sugar fluid with a radioactive material attached to it is injected into a catheter (plastic tube) that has been inserted into a vein in the patient's arm. The scanner detects ...

Depression is a devastating illness that is estimated to affect 12% to 17% of the population at some point during the lifetime of an individual. Despite the availability of a wide range of antidepressant drugs, 30% to 40% of patients with major depression fail to respond to first-line antidepressant (e.g., selective serotonin reuptake inhibitors (SSRIs)) treatment, despite adequate dosage, duration, and compliance. Thus there is a clear need to develop novel and improved therapeutics for major depression. Current pathophysiological theories regarding the neurobiology of depression include alterations in intracellular signaling cascades, and impairments of cellular plasticity and resilience. There is recent evidence suggesting that promoting growth factors such as brain derived neurotrophic factor (BDNF) may provide a mechanism for the treatment of depression. New information indicating modulation of glutamate receptors in the actions of antidepressant treatments suggests a novel approach to develop a new class of antidepressants. Studies have shown that the biarylpropylsulfonamide AMPA (2-amino-3-(5-methyl-3-oxo-1,2-oxazol-4-yl) propanoic acid) receptor potentiators (LY392098 and LY451616) have antidepressant effects in animal models of depression. Several studies have demonstrated that AMPA receptor activation can increase expression of BDNF both in vitro and in vivo. Thus, one possible new approach for the treatment of depression is to use an AMPA receptor potentiator. In this study we propose to compare the ampakine receptor potentiator Org 24448 to placebo for the treatment of Major Depression. Inpatients and outpatients (primarily outpatients), ages 21 to 70, with a diagnosis of Major Depression (without psychotic features), will be randomized to double-blind treatment to either Org 24448 or placebo for a period of 8 weeks. Acute efficacy will be determined by demonstrating a greater response rate using specified criteria. Approximately 90 patients with acute major depression will be enrolled in the study in order to reach the goal of randomizing 70 patients in the controlled trial.

Depression

Depression Glutamate Ampakine Treatment Memory Major Depressive Disorder AMPA Receptor Activation BDNF

null

2

arm 1: Blinded, active experimental compound arm 2: Blinded placebo

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: 250 mg once per day for first week, 250 mg twice per day for second week, 500 mg twice per day for third and fourth weeks, if response minimal or worse at four weeks then 750 mg twice per day for additional weeks intervention 2: Inactive equivalent of 250 mg once per day for first week, 250 mg twice per day for second week, 500 mg twice per day for third and fourth weeks, if response minimal or worse at four weeks then 750 mg twice per day for additional weeks

intervention 1: Org 24448 intervention 2: Placebo

2

0

NCT00113022

[ 4 ]

1,086

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

The purpose of this study is to determine the long-term safety of febuxostat, once daily (QD), compared to allopurinol in reducing serum urate levels in subjects with gout.

Uric acid is the end product of purine degradation in humans. Hyperuricemia, a urate concentration in serum exceeding the limit of urate solubility (approximately 7.0 mg/dL), is a common biochemical abnormality. Aberrations in any of the multiple mechanisms involved in the production and/or excretion of uric acid may increase serum urate concentrations, with persistent hyperuricemia as a marker for extracellular fluid monosodium urate supersaturation. As such, hyperuricemia is a necessary (but often insufficient) risk factor for monosodium urate crystal deposition in tissues and is the fundamental pathophysiological process underlying the clinical manifestations of gout, which is a chronic disease characterized by urate crystal formation and deposition in joints and bones. Gout may progress from episodic attacks of acute inflammatory arthritis to a disabling chronic disorder characterized by deforming arthropathy; destructive deposits of urate crystals (tophi) in bones, joints, and other organs; structural and functional renal impairment due to interstitial urate crystal deposition; and urinary tract stones composed entirely or partially of uric acid crystals. Management of gout requires chronic treatment aimed at lowering serum urate levels into a subsaturating range (usually \<6.0 mg/dL) in which crystal formation and deposition are prevented or reversed. Febuxostat (TMX-67) is a non-purine selective xanthine oxidase inhibitor being developed as an orally administered agent for the management of hyperuricemia in patients with gout. This study was originally designed and initiated having all subjects initially assigned to 80 mg febuxostat provided as an 80 mg tablet, to be administered orally. Subjects could be titrated to 120 mg, provided as one 40 and 80 mg tablet, between Months 2 and 6, if their serum uric acid rose \> 6.0 mg/dL; the dose could be down-titrated to 80 mg if the serum uric acid decreased to \< 3.0 mg/dL. The protocol was amended to add a comparator arm, and to have subjects randomized to 80 or 120 mg febuxostat or allopurinol (100 or 300 mg, dependent on renal function). The information below reflects the treatments following the implementation of the revised protocol.

Gout

uric acid xanthine oxidase hyperuricemia tophi Drug Therapy

null

3

arm 1: None arm 2: None arm 3: None

[ 0, 0, 1 ]

3

[ 0, 0, 0 ]

intervention 1: Febuxostat 80 mg, tablets, orally, once daily. intervention 2: Febuxostat 120 mg, tablets, orally, once daily. intervention 3: Allopurinol 100 mg or 300 mg, tablets, orally, once daily.

intervention 1: Febuxostat intervention 2: Febuxostat intervention 3: Allopurinol

0

null

0

NCT00175019

[ 4 ]

24

RANDOMIZED

CROSSOVER

0TREATMENT

4QUADRUPLE

false

0ALL

false

The purpose of this clinical study (ChAMP - Comparability pharmacokinetics of Alpha-1 Modified Process) is to compare the pharmacokinetic, safety and tolerability of Alpha-1 Proteinase Inhibitor (Human), modified process (Alpha-1 MP) and Prolastin in adult Alpha1-antitrypsin deficient patients. Patients will be infused intravenously with study drug on a weekly schedule for 24 weeks.

The objective of this study is to demonstrate the pharmacokinetic comparability of Alpha-1 MP to Prolastin® in subjects with Alpha1-antitrypsin deficiency. This study is divided into three 8-week treatment sequences including an initial 8-week double-blind treatment period (with one of the 2 study drugs), a second 8-week double-blind treatment period (with the other study drug), and a third 8-week open-label treatment period (with Alpha-1 MP).

Alpha 1-Antitrypsin Deficiency

alpha 1-Antitrypsin Deficiency alpha 1-Antitrypsin pulmonary emphysema

null

2

arm 1: Sequential, blinded treatment periods of Alpha-1 MP (experimental), then crossed-over to Prolastin (active comparator), followed by open-label Alpha-1 MP arm 2: Sequential, blinded treatment periods of Prolastin (active comparator), then crossed-over to Alpha-1 MP (experimental), followed by open-label Alpha-1 MP

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: alpha-1 proteinase inhibitor (human), 60 mg/kg body weight intervention 2: Prolastin

intervention 1: Alpha-1 MP intervention 2: alpha-1 proteinase inhibitor (human)

8

0

NCT00295061

[ 3 ]

35

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

null

This study evaluates the safety of plerixafor and other outcomes that are purely exploratory in nature. One other pre-specified outcome is to evaluate an interval of 10-11 hours between dosing with plerixafor and the beginning of apheresis to determine if there will be at least a 2-fold increase in circulating CD34+ cells. Data from this protocol will assist in the determination of the dosing schedule for future studies.

Participants with non-Hodgkin's lymphoma and multiple myeloma who have undergone prior cyto-reductive chemotherapy and are to be autologously transplanted will be treated with a combination of plerixafor and granulocyte colony-stimulating factor (G-CSF) mobilization regimen on the day prior to apheresis. The only change to standard of European care is the addition of plerixafor to a G-CSF mobilizing regimen. Participants will undergo mobilization with G-CSF (10 µg/kg each day) and on each day prior to apheresis will receive plerixafor (240 µg/kg). Participants will undergo apheresis for up to 5 consecutive days in order to collect the target number of (≥ 5\*10\^6) CD34+ stem cells/kg. Participants will be transplanted with cells obtained from the G-CSF and plerixafor mobilization regimen. The number of CD34+ cells mobilized in the peripheral blood from the time of the plerixafor dose to just prior to apheresis and those harvested in the apheresis product will be measured. The number of apheresis sessions required to obtain ≥ 5\*10\^6 CD34+ cells/kg will also be measured. Success of the transplantation(s) will be evaluated by the time to engraftment of poly-morphonuclear leukocytes (PMN) and platelets (PLT). Participants will be followed for durability of their transplant for 12 months following transplantation. This study was previously posted by AnorMED, Inc. In November 2006, AnorMED, Inc. was acquired by Genzyme Corporation. Genzyme Corporation is the sponsor of the trial.

Lymphoma, Non-Hodgkin Multiple Myeloma

Non-Hodgkin's lymphoma Multiple Myeloma Stem cell mobilization

null

2

arm 1: Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5\*10\^6 CD34+ cells/kg were collected. arm 2: Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5\*10\^6 CD34+ cells/kg were collected.

[ 0, 0 ]

1

[ 0 ]

intervention 1: Participants underwent mobilization with G-CSF 10 µg/kg/day for 4 days, administered by subcutaneous injection (SC) injection each morning. On the evening of Day 4, participants received a dose of plerixafor 240 µg/kg, administered by SC injection. On Day 5, participants returned to the clinic and received a morning dose of G-CSF 10 µg/kg and underwent apheresis approximately 10 to 11 hours after the dose of plerixafor (within 60 minutes after administration of G-CSF). Participants continued to receive an evening dose of plerixafor followed the next day by a morning dose of G-CSF and apheresis for up to a maximum of 5 aphereses or until ≥ 5\*10\^6 CD34+ cells/kg were collected.

intervention 1: G-CSF Plus Plerixafor

3

Cologne | N/A | Germany | 6.95 | 50.93333 Dresden | N/A | Germany | 13.73832 | 51.05089 Heidelberg | N/A | Germany | 8.69079 | 49.40768

0

NCT00322842

[ 3 ]

49

RANDOMIZED

SINGLE_GROUP

0TREATMENT

2DOUBLE

false

2MALE

false

A phase 2a study to investigate the effects of 7-day monotherapy of UK-453,061 on viral load response in asymptomatic human immunodeficiency virus (HIV) infected subjects, to assess the dose-response relationship, and to assess the pharmacokinetics (PK), safety and tolerability of UK-453,061 in asymptomatic HIV infected subjects.

null

HIV-1

null

2

arm 1: None arm 2: None

[ 0, 0 ]

2

[ 0, 0 ]

intervention 1: Placebo BID, Placebo QD, UK-453,061 10 mg BID, 30 mg BID, 100 mg BID or 500 mg QD for 7 days intervention 2: Placebo BID, Placebo QD, UK-453,061 100 mg QD, 500 mg BID or 750 mg QD for 7 days

intervention 1: UK-453,061 intervention 2: UK-453,061

3

Cologne | N/A | Germany | 6.95 | 50.93333 Frankfurt am Main | N/A | Germany | 8.68417 | 50.11552 Hamburg | N/A | Germany | 9.99302 | 53.55073

0

NCT00348673

[ 5 ]

95

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

null

This is a multicenter, randomized trial to compare the safety and efficacy of two dosing frequencies of Cerezyme® in patients with Gaucher disease who are currently being treated with Cerezyme®. Approximately 90 patients will be randomized in a 2:1 (q4 : q2) ratio to one of two treatment arms at up to 26 study centers worldwide. Patients will continue to receive the same total 4-week dose that they were receiving prior to study enrollment, however, they will be randomized to receive either their total 4-week dose in two infusions, one infusion every 2 weeks or their total 4-week dose in one infusion every 4 weeks. The randomization scheme will ensure a 2:1 balance between the every 4-week versus every 2-week infusion groups, respectively.

null

Gaucher Disease, Type 1 Cerebroside Lipidosis Syndrome Glucocerebrosidase Deficiency Disease Glucosylceramide Beta-Glucosidase Deficiency Disease Gaucher Disease, Non-Neuronopathic Form

Type 1 Gaucher Disease Glucocerebrosidase Deficiency Disease

null

2

arm 1: Patients receiving Cerezyme one infusion every 2 weeks (Q2). arm 2: Patients receiving Cerezyme one infusion every 4 weeks (Q4).

[ 5, 5 ]

1

[ 0 ]

intervention 1: Cerezyme doses of 20-60U/kg every 2 weeks (Q2 Arm) or 40-120 U/kg every 4 weeks (Q4 Arm).

intervention 1: Cerezyme

26

0

NCT00364858

[ 3 ]

215

RANDOMIZED

PARALLEL

1PREVENTION

0NONE

false

0ALL

null

Randomized study of PRT054021 40 mg and 15 mg bid vs. enoxaparin 30 mg q12h for the prophylaxis of venous thromboembolic events after unilateral knee replacement surgery.

Approximately 200 patients undergoing unilateral knee replacement will be entered into the study and randomized to receive either enoxaparin 30 mg sq bid, PRT054021 15 mg po bid, or PRT054021 40 mg po bid for 10 to 14 days, at which time patients will undergo venography.

Thromboembolism

Prevention of Venous Thromboembolism

null

3

arm 1: Betrixaban 15 mg oral twice daily for 10 to 14 days arm 2: Betrixaban 40 mg oral twice daily for 10 to 14 days arm 3: Enoxaparin 30 mg administered subcutaneously every 12 hours for 10 to 14 days

[ 0, 0, 0 ]

2

[ 0, 0 ]

intervention 1: Capsule intervention 2: Administered subcutaneously

intervention 1: Betrixaban intervention 2: Enoxaparin

1

Montreal | Quebec | Canada | -73.58781 | 45.50884

0

NCT00375609

[ 2 ]

40

RANDOMIZED

CROSSOVER

null

0NONE

true

1FEMALE

false

The objective of this study was to determine and compare the rate and extent of absorption of norethindrone and unconjugated estradiol from a test formulation of Estradiol/Norethindrone Acetate Tablets, 1 mg/0.5 mg versus the reference Activella® (1 mg estradiol/0.5 mg norethindrone acetate) Tablets under fed conditions.

Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA Bioequivalence Statistical Methods

Healthy

Bioequivalence Healthy Subjects

null

2

arm 1: Estradiol/Norethindrone Acetate Tablets, 1 mg/0.5 mg arm 2: Activella® (1 mg estradiol/0.5 mg norethindrone acetate) Tablets

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: 1 mg/0.5 mg Tablets intervention 2: 1 mg/0.5 mg Tablets

intervention 1: Estradiol/Norethindrone acetate intervention 2: Activella®

1

Toronto | Ontario | Canada | -79.39864 | 43.70643

0

NCT01181726

[ 3 ]

48

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

true

This Phase 2 study is to determine whether WR279396 with occlusion (a polyurethane dressing) is more effective than WR279396 without occlusion for once daily treatment. Extensive objective and subjective local tolerance data will also be captured during this trial, as well as surrogate markers (parasite loads and aminoglycosides concentration in the deep dermis) that may help to determine the optimal number and duration of treatments. The results from this study will help determine the most practical treatment schedule and will answer questions that are crucial to improve the present treatment regimen with WR279396 which is twice a day for 20 days.

Forty-eight patients (48) with Old World cutaneous leishmaniasis will be randomly allocated to WR279396 treatment once a day for 20 days with an optimized polyurethane dressing (occlusion) (24 patients), or without occlusion (24 patients). All patients will be rescued with the standard of care accepted in Tunisia, if the patient is not cured. The active ingredients of WR279396 are two aminoglycosides - paromomycin sulphate (15%) and gentamicin sulphate (0.5%) - in a base (AQIC). Each subject will be followed for clinical cure for 90 days after the initiation of treatment. Cure is defined as 100% reepithelialization without relapse by 3 months. Tolerance will be evaluated by local adverse reactions and by laboratory signs of systemic events. In addition to the clinical evaluation of the CL lesions, the following parameters/clinical healing surrogates will be investigated: 1. parasite load will be determined in superficial and deep lesional dermis samples at D0 and D10. The mean parasite reduction ratio (parasite load at D10/parasite load at D0) in each group will be compared; 2. aminoglycoside concentrations in superficial and deep infiltrated dermis in each group will be compared.

Old World Cutaneous Leishmaniasis

Ointment to treat leishmania skin lesions

null

2

arm 1: 24 patients will be randomly allocated to WR279,396 treatment once-a-day for 20 days with using an occlusive polyurethane Tegaderm dressing arm 2: 24 subjects will be randomly allocated to WR279,396 treatment once a day for 20 days without an optimized polyurethane dressing (gauze and tape only).

[ 0, 0 ]

2

[ 0, 0 ]

intervention 1: Ointment containing paromomycin sulphate (15%) and gentamicin sulphate (0.5%) - in a base (AQIC)applied for 20 days with polyurethane dressing intervention 2: Ointment containing paromomycin sulphate (15%) and gentamicin sulphate (0.5%) - in a base (AQIC)applied for 20 days

intervention 1: WR279,396 with Tegaderm Dressing intervention 2: WR 279,396 with Gauze and Tape Dressing

1

Tunis | N/A | Tunisia | 10.16579 | 36.81897

0

NCT01536795

[ 2 ]

16

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

true

0ALL

false

Randomized, double-blind, placebo-controlled, sequential multiple ascending dose study to determine a maximum tolerated dose

This study was designed as a randomized, double-blind, placebo-controlled, sequential multiple ascending dose study to assess the safety and pharmacokinetics of supratherapeutic doses of eslicarbazepine acetate in 32 healthy adult male and female subjects, with 8 subjects per treatment group. In each study group, subjects were to receive single doses of eslicarbazepine acetate or placebo once daily for 5 days. A series of screening evaluations was performed within a 21-day period prior to the first dose of study medication in order to determine the eligibility of prospective study participants for the trial. Eligible subjects reported to the clinic on Day -1 prior to study medication administration and remained in the clinic until clinic discharge on Day 7. Plasma and urine samples were collected throughout the study to determine the pharmacokinetics of eslicarbazepine acetate and its metabolites.

Epilepsy

Anticonvulsant

null

3

arm 1: Matching placebo tablets for oral administration arm 2: Subjects in Cohort 2 received a dose of 3000 mg once daily (5 x 600 mg eslicarbazepine acetate tablets) arm 3: Subjects in Cohort 1 received a dose of 3600 mg once daily (6 x 600 mg eslicarbazepine acetate tablets)

[ 2, 0, 0 ]

3

[ 0, 0, 0 ]

intervention 1: Matching placebo tablets for oral administration intervention 2: Eslicarbazepine acetate 600 mg tablets for oral administration intervention 3: Eslicarbazepine acetate 600 mg tablets for oral administration

intervention 1: Placebo intervention 2: BIA 2-093 3000 mg once daily intervention 3: BIA 2-093 3600 mg once daily

1

Miramar | Florida | United States | -80.23227 | 25.98731

0

NCT01879332

[ 2 ]

32

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

true

2MALE

false

Single centre, open-label, multiple doses, one-sequence design study in two parallel groups of healthy volunteers

Single centre, open-label, multiple doses, one-sequence design study in two parallel groups of healthy volunteers: Group A: Pre-treatment with ESL, treatment with ESL and ascending doses of Topamax (TPM) in last phases; Group B: Pre-treatment with TPM, treatment with TPM and ascending doses of ESL in last phases

Epilepsy

null

2

arm 1: Group A * Pre-treatment: 600 mg once daily dose of eslicarbazepine acetate (ESL) administered for two consecutive days; * Treatment 1: 1200 mg once daily dose of eslicarbazepine acetate (ESL) administered for six consecutive days * Treatment 2: Concomitant doses of eslicarbazepine acetate (ESL) 1200 mg and TPM 100 mg for two consecutive days * Treatment 3: Concomitant doses of eslicarbazepine acetate (ESL) 1200 mg and TPM 100 mg (morning) + 100mg (evening) for two consecutive days * Treatment 4: Concomitant doses of eslicarbazepine acetate (ESL) 1200 mg and TPM 200 mg for fifteen consecutive days arm 2: * Pre-treatment: 100 mg once daily dose of TPM administered for two consecutive days; * Pre-treatment 2: 100 mg twice daily dose of TPM administered for two consecutive days; * Treatment: 200 mg once daily dose of TPM administered for four consecutive days; * Treatment 2: Concomitant doses of eslicarbazepine acetate (ESL) 600 mg and TPM 200 mg for two consecutive days * Treatment 3: Concomitant doses of eslicarbazepine acetate (ESL) 1200 mg and TPM 200mg for seventeen consecutive days

[ 0, 0 ]

2

[ 0, 0 ]

intervention 1: None intervention 2: None

intervention 1: BIA 2-093 intervention 2: Topamax

0

null

0

NCT02283814

[ 3 ]

5

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

Current therapies for Non-Hodgkin's Lymphoma provide limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of Non-Hodgkin's Lymphoma. PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on patients with Non-Hodgkin's Lymphoma.

OBJECTIVES: * Determine the safety and possible effectiveness of antineoplastons A10 and AS2-1 in patients with non-Hodgkin's lymphoma who have failed high-dose chemotherapy and bone marrow transplantation. * Describe the response to, tolerance to, and side effects of this regimen in these patients. Non-Hodgkin's Lymphoma patients receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached. Treatment continues up to 12 months in the absence of disease progression or unacceptable toxicity. OBJECTIVES: * To determine the efficacy of Antineoplaston therapy in patients with Non-Hodgkin's Lymphoma, as measured by an objective response to therapy (complete response, partial response or stable disease). * To determine the safety and tolerance of Antineoplaston therapy in patients with Non-Hodgkin's Lymphoma. * To determine objective response, tumor size is measured utilizing physical examination, radiologic studies, and bone marrow biopsies as necessary, performed every 8 weeks for the first two years, every 3 months for the third and fourth years, every 6 months for the 5th and sixth years, and annually thereafter.

Non Hodgkin Lymphoma

Non Hodgkin Lymphoma Recurrent Non Hodgkin Lymphoma Refractory

null

1

arm 1: Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.

[ 0 ]

1

[ 0 ]

intervention 1: Patients with Non-Hodgkin's Lymphoma will receive Antineoplaston therapy (Atengenal + Astugenal). The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1.

intervention 1: Antineoplaston therapy (Atengenal + Astugenal)

1

Houston | Texas | United States | -95.36327 | 29.76328

0

NCT00003498

[ 4 ]

701

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

null

The purpose of this study is to determine the safety and efficacy of an investigational drug in patients with type 2 diabetes mellitus.

null

Diabetes Mellitus, Type II

Type 2 Diabetes Mellitus

null

2

arm 1: The Sitagliptin 100 mg group includes patients who were administered once-daily treatment with oral tablets of sitagliptin 100 mg during Phase A (Weeks 0-24) of the treatment period. During Phase B (Weeks 24-104) of the treatment period these patients received once-daily coadministered treatment with oral tablets of sitagliptin 100 mg and glipizide-matched placebo. arm 2: The Placebo/Glipizide 5 mg group includes patients who were administered once-daily treatment with oral tablets of sitagliptin-matched placebo during Phase A (Weeks 0-24) of the treatment period. During Phase B (Weeks 24-104) of the treatment period these patients received once-daily coadministered treatment with oral tablets of sitagliptin-matched placebo 100 mg and glipizide 5 mg which was allowed to be uptitrated, in a blinded fashion, to a maximum dose of 15 mg/day.

[ 0, 2 ]

4

[ 0, 0, 0, 0 ]

intervention 1: Sitagliptin 100 mg once daily, from Visit 4 through Final Visit, week 104 intervention 2: Placebo (to match Sitagliptin 100 mg) from Visit 4 through Visit 8; Glipizide 5 mg from Visit 8, week 24 to Final Visit (Week 104) intervention 3: Metformin 1500 mg, once daily, from Visit 2 to Final Visit (Week 104) intervention 4: Pioglitazone 15 mg once daily, for patients not meeting specific glycemic goals during the placebo-controlled treatment period \[Phase A\], from Visit 5 (Week 6) to Visit 8 (Week 24)

intervention 1: Sitagliptin (MK0431) intervention 2: Placebo/Glipizide 5 mg intervention 3: Metformin intervention 4: Pioglitazone

0

null

0

NCT00086515